**MEETING OF THE DENTAL PRODUCTS PANEL**

**November 3-5, 1997**

**OPEN SESSION**

**Bethesda Holiday Inn**

**8120 Wisconsin Avenue**

**Bethesda, Maryland**

**Panel Participants**

**November 3, 1997**

**Acting Chair**

Dr. Robert J. Genco

**Executive Secretary**

Ms. Pamela Scott

**Panel Members**

Dr. Janine E. Janosky

**Panel Consultants**

Dr. Gilbert Gonzalez

Dr. Leslie Heffez

Dr. Andrea Morgan

Dr. Elizabeth Diane Rekow

**Consumer Representative**

Dr. Donald S. Altman

**Industry Representative**

Mr. Floyd Larson

**Guests**

Dr. Peter Bertrand

Dr. Barry Cooper

Dr. Allen Moses

**FDA Participants**

Dr. Robert Betz

Dental Officer

Dental Devices Branch

Ms. Angela Blackwell

Biomedical Engineer/Dental Reviewer

Dental Devices Branch

Dr. Susan Runner

Branch Chief

Dental Devices Branch

Dr. Sandra Shire

Dental Officer

Dental Devices Branch

Mr. Timothy A. Ulatowski

Division Director

Division of Dental, Infection Control, and General Hospital Devices

**OPEN SESSION\--NOVEMBER 3, 1997**

Dr. Robert Genco, Acting Chair, opened the session at 9:05 a.m.
Executive Secretary Pamela Scott introduced the panel members and read
the conflict of interest statement, noting that there were no conflict
of interest matters to be declared concerning the panel. She also read
the appointment to acting panel chair for Dr. Genco and introduced Drs.
Peter Bertrand, Barry Cooper, and Allen Moses as invited guests. Dr.
Genco introduced Mr. Timothy A. Ulatowski, Director of the Division of
Dental, Infection Control, and General Hospital Devices, and Dr. Susan
Runner, Chief of the Dental Devices Branch.

Dr. Runner updated the panel on two developments since the last meeting
in February. The Panel recommended that the mandibular condyle implants
for temporary reconstruction of the mandibular condyle in patients who
have undergone surgical procedures to remove malignant or benign tumors,
requiring the removal of the mandibular condyle be reclassified to class
II. Dr. stated that the proposed reclassification notice will be
published in the Federal Register. The FDA had also signed a recent Memo
of Understanding with the National Institute for Dental Research
concerning collaborative activities such as trading panel members and
residents and assisting with product evaluation. This memo marks one of
the first such ventures; activities will begin next year.

Mr. Ulatowski updated the panel on an initiative underway in both the
Dental Devices Branch and the Center for Devices and Radiological Health
to identify international and domestic voluntary consensus standards to
assist the FDA in evaluating products. The FDA is working with
standard-based organizations to develop a list of such standards for
assessment and possible acceptance. FDA acceptance of a standard means
that devices certified as meeting that standard would not be required to
produce further data or information for FDA consideration regarding the
particular aspect of the device that meets the standard. He noted a
publication already on the Internet concerning FDA acceptance of
electrical standards and predicted others as efforts continue to make
the FDA a more standard-based organization.

Mr. Ulatowski introduced the first panel topic: a discussion of how to
categorize devices for use in the diagnosis and/or treatment of
temporomandibular joint dysfunction and oral-facial pain. He noted that
the FDA was required by the 1976 Medical Devices Amendments Act to
classify all medical devices into class I, II, or III, depending on the
level of regulatory control necessary to provide a reasonable assurance
of safety and effectiveness. The discussion was to focus on
preamendments devices heretofore unclassified and to identify a
comprehensive listing of generic types of devices used for
temporomandibular joint dysfunction and oral-facial pain. Actual
classification of each generic type would occur at a future panel
meeting, during which safety and effectiveness for each type of generic
device would also be evaluated.

Mr. Ulatowski explained that post-1976 new devices can enter the market
through various regulatory paths. Many class I devices are exempt from
the 510 (k) process, and there is a trend toward exempting all class I
devices from that process. Class III devices require premarket approval
applications (PMAs). New devices can also enter the market via a 510 (k)
application using the claim of substantial equivalence to a legally
marketed device, either one that is already classified or a pre-1976
unclassified device. If FDA review of the 510 (k) determines equivalence
and the new device enters the market, a chain of equivalence can thus be
established. (Those devices not deemed equivalent become class III
devices subject to the PMA or product development protocol process.) Mr.
Ulatowski listed some questions that could be used to determine generic
types of classifications. He also showed examples of regulatory
classifications and variations in classifications even within the same
device type depending on varying risk factors and intended use.

**FDA PRESENTATION**

Dr. Robert Betz, Dental Officer from the Dental Devices Branch, began
the FDA presentation by noting disagreement in the dental literature
over temporomandibular joint (TMJ) related terminology and over terms
such as "myofacial" and "orofacial." He stated that the Dental Branch
considered myofacial pain to be a subset of orofacial pain. He
reiterated that the focus of the meeting was on the inventory and
grouping of generic types of devices used for the diagnosis and/or
treatment of temporomandibular joint dysfunction and oral-facial pain.
He urged the panel to let the FDA know what information or data would
facilitate future device classification. Dr. Betz asked panel members to
discuss the existing physical description of the device group, the
indications for use in the labeling, and the function of devices for
each group of generic type of device in order to produce a
panel-recommended chart. The FDA would then review the chart and use it
to identify devices to be classified at future panel meetings.

The Dental Branch had previously generated a draft list of generic
device groups for discussion purposes, which Dr. Betz presented. He
noted the intentional omission of custom intra-oral devices, which are
not subject to premarket review, and listed seven device groupings:
electromyography, sonography, stimulatory (including TENS), kinesiology
(including pantographic tracing), ultrasound, thermography, and imaging
(including radiographic, tomography, magnetic resonance, and diagnostic
ultrasound). For each category he gave a device description, intended
use, and indications for use as related to the diagnosis and/or
treatment of TMJ disorders and associated orofacial pain. Dr. Betz then
listed questions for the panel to consider in discussing the chart.

Dr. Genco thanked Mr. Ulatowski and Dr. Betz for their presentations and
opened the floor for the public hearing.

**OPEN PUBLIC HEARING**

There were no new requests to address the panel during the Open Public
Hearing.

**INDUSTRY PRESENTATIONS**

Dr Genco then proceeded to the next agenda item, the industry
presentations.

**Mr. John Radke** of **Bioresearch, Inc.**, began the industry
presentations. He stated that he had been present for the panel meeting
three years previously during which the Panel had recommended
classification of muscle monitoring devices as class III devices subject
to PMA, despite the lack of real evidence of any public harm over the
previous 20 years of use. He pointed out that small firms such as
Bioresearch could not underwrite the costs involved in submitted a PMA
application and that their products, if classified as class III, would
be "finished" and of no help to the public or the industry. Mr. Radke
described the four basic devices marketed by his company. These devices
include an electromyograph, a TENS device, a device for tracking jaw
movements, and a device for recording joint sounds. He noted that TMJ
dysfunction is not a single, simple entity and that no single device can
diagnose it on its own. He argued that devices should be classified by
device type rather than the anatomical site on which they are used. For
example, an electromyograph should be classified with other
electromyograph devices whether the site of application is a shoulder
muscle or facial muscle.

Panel comments after Mr. Radke's remarks suggested differentiating
devices within categories on the basis of treatment versus diagnosis and
on the basis of invasive versus noninvasive procedures.

**Mr. Roland Jankelson** of **Myo-Tronics, Inc**. recapped the history
of this issue as it related to his firm since the 1994 panel meeting. He
stated that as a result of which there was a two-year investigation by
the Office of the Inspector General and hearings in the House of
Representatives. The FDA had since acknowledged problems during this
time, and Mr. Jankelson expressed his pleasure at seeing new faces on
the 1997 panel. He noted that he had submitted four letters to the
panel's Executive Secretary raising issues relevant to the day's agenda
but had not yet received a reply. He suggested that the issue of a
generic classification versus a finite classification was a significant
question to be addressed.

**Mr. Robert Jankelson**, a private specialist in TMJ disorders and a
stockholder in Myo-Tronics, listed four major areas of discussion
specific to classification of devices used for temporomandibular joint
dysfunction and orofacial pain. First, the panel must have a full
understanding of the scope and complexity of the multi-etiologic TMD
complex and a clear definition of it. Second, it must be aware of the
political and scientific history of the two major TMD paradigms, the
biomechanical and the psychosocial, both of which should be included in
the pathogenic model for TMD. The panel must also understand the broad
scope of diagnostic, therapeutic, and psychometric devices that must be
considered for use in the diagnosis and/or treatment of TMD, of which he
listed 25 types. Finally, the panel must understand the distinction
between measurement devices that provide data to assist the clinician in
TMD diagnosis and treatment and those that are claimed to independently
make a diagnosis. Dr. Jankelson listed three criteria relevant in
considering devices that aid in the diagnosis of TMD: whether the device
measures a known physiologic phenomenon, whether the data measurement is
accurate, and whether the data provide additional relevant information
for the diagnosis.

**Dr. Kenneth Burrell** of the **American Dental Association (ADA**)
discussed the criteria used by the ADA's Council on Scientific Affairs
to evaluate TMD diagnostic and treatment devices for possible acceptance
under the ADA seal program. He defined temporomandibular disorders or
TMD as encompassing a number of musculoskeletal conditions that involve
one or both temporomandibular joints, the masticatory muscles, or a
combination of both. He outlined product information that must be
submitted such as efficacy claims, product description, design
principles, packaging and instructional materials, limitations and
sources of errors, precautions, contraindications, and calibration
procedures. He specified what must be provided for TMD diagnostic aids,
treatment devices, or both types, and stated that measurement devices
are evaluated by performance standards, whereas diagnostic devices
require clinical trial data. He outlined examples of safety and
performance standards and assessments such as reliability and validity
studies and sensitivity and specificity data for TMD diagnostic aids.
Dr. Burrell reviewed the information and documentation required for TMD
treatment devices as well as ADA's classification system. He discussed
the criteria involved in the two required, independent, randomized
clinical efficacy trials. He noted that the Association considers
instruments only as aids in diagnosis of TMD and that seven devices for
evaluation of TMD carry the ADA seal. The ADA Council determines a
statement that accepted TMD treatment devices carry upon approval of
each product, but there are no products on the ADA's list of accepted
products that have been shown to be useful in the treatment of TMD.

Panel discussion after Dr. Burrell's presentation noted that the ADA
standards could be considered as voluntary consensus standards for the
FDA to consider adopting.

**Dr. Peter Neff** spoke on behalf of Dr. Terri-Ross Icyda of the
**Equilibration Society**, stating that the Society's position is that
the clinician, not the instrument, makes the diagnosis of TMD and
determines the treatment.

**Dr. Larry Tilley** of the American Academy of Head, Neck, and Facial
Pain spoke on behalf of the **American Alliance of TMD Organizations**,
a group that he said crystallized in response to the 1994 panel hearing.
He noted the divisive and emotional nature of TMD, and he outlined the
chronology of events and publications concerning TMD since 1986. He
underlined the need to address interobserver reliability, range of
motion, quality and symmetry of jaw movements, and joint sounds through
clinical studies and research. He stated that the detractors of
electronic instrumentation forced dentists into making diagnoses without
the benefit of instrumentation and that more studies were needed to get
consensus on instrumentation regardless of classification. He commented
that clinicians rather than devices determine diagnoses and he asked for
a thoughtful approach and a committee of integrity.

**OPEN COMMITTEE DISCUSSION**

Dr. Ulatowski thanked the speakers for their comments, particularly on
the need for a working definition of TMD and on the scope of products
involved. He reminded the panel that the FDA exists to regulate devices,
not the practice of dentistry, and that dentists can use legally
marketed devices as they see fit. He also noted that some products and
devices mentioned are not medical devices as defined in the
classification regulations. The task of the panel was to classify
devices as defined and labeled by finding the highest common denominator
of devices to be regulated and selecting groups that do not differ
significantly in major ways. He repeated the questions posed earlier to
the panel.

Panel discussion focused first on the question of how to define the
disease or disorder of TMD or TMJ. Dr. Moses suggested considering it a
subset of myogenous periarticular masticatory orofacial pain rather than
psychogenic pain. Dr. Bertrand felt that it was important to look at the
full extent of muscles and functions involved in the trigeminal system
and that to consider TMD psychogenic was misleading because it could be
neurogenic. Dr. Genco acknowledged the complexity of the diagnosis but
suggested that orofacial pain and/or jaw dysfunction were the key
characteristics under consideration. After discussion, the panel
consensus was to consider devices used in the diagnosis and/or treatment
of temporomandibular disorders and/or associated pain and/or
dysfunction.

The panel then focused on what constituted a device and whether software
could be considered a device. It was noted that many psychometric tests
are software that attribute the TM disorder to physical or mental
causes; some of the industry spokespeople present felt that such
products should not be excluded from discussion. Mr. Ulatowksi stated
that the FDA was not excluding any product a priori but would not
classify such products until they are ruled devices. Information is
forthcoming on whether freestanding software constitutes a device.

The panel considered all eight questions for each proposed device
grouping. It was agreed to consider **electromyograph devices** as a
generic group with two main categories: (1) to measure masticatory and
associated muscle electrical activity and (2) to aid through biofeedback
in reducing muscle activity. All 510 (k)s in this group were
unclassified or equivalent to unclassified devices except for a
biofeedback physical medical device, which would be subject to
classification, possibly as class II, later. Information needed prior to
classification included adverse reaction reports on any product
mentioned here and appropriate literature reports on clinical efficacy
results relating to muscle activity measurement. The need for
randomized, controlled, good quality clinical trials or at least the use
of sequential patients was noted, as was the need for reports and
literature from professionals and associations relating to TMD. This
category was assigned low priority.

It was agreed to limit the **stimulatory devices category** to **TENS
devices**, to treat by application of electrical energy to the
temporomandibular region for pain control and muscle relaxation. TENS
devices would be subdivided into two subcategories of high and low
frequency devices. There is one 510 (k) application for TMJ use based on
substantial equivalence to an unclassified predicate device. It was
noted that blinded studies will not be possible for high frequency
devices. This category was assigned low priority.

The panel agreed on the category of **sonography devices** to measure
and graphically display or represent sounds made by TMJ components.
There are class II devices in this area but the dental predicate device
was unclassified. This category was assigned low priority.

The **jaw kinesiology category** was renamed **jaw tracking devices**,
with subcategories of jaw kinesiology and pantographic tracing devices,
because the common denominator is measurement of jaw movement and
position but the dynamics are different. The indications for use remain
to measure and graphically record jaw movement in three dimensions. It
was noted that there are class I or class I exempt pantographic devices
for prosthetic dental uses but not specifically for TMD, and that there
are unclassified pre-1976 predicate devices in kinesiology that will
probably be reclassified. This category was assigned low priority.

It was noted that in the categories of **ultrasound, thermography, and
imaging devices**, there are no devices with claims related to TMD or
orofacial pain. Panel members debated whether devices in these areas
should be classified by site or disease-specific indications and whether
these categories should be included if there are no devices with related
claims in these areas. FDA representatives pointed out that once
products are cleared, they can be used as practitioners see fit and that
devices may be used for TMD off -label and should still be addressed

It was suggested that other categories be added such as **occlusal
evaluating devices; occlusal therapy implementing devices; free standing
software; and iontophoresis.**

A representative from Myo-Tronics asked hypothetically whether his
company's devices could avoid reclassification by removing all
references to TMD uses and whether other device manufacturers who avoid
TMD claims are avoiding reclassification by being less forthright. It
was suggested that if the panel has a new perspective on safety and
efficacy relative to the 1994 panel, the burden of proof should be
shifted to assume substantial equivalence in favor of the manufacturer.
Mr. Ulatowski replied that the FDA needed to take stock of the position
and have more information before any reclassification decisions were
made. Mr. Jankelson of Myotronics observed that the conclusion of the
panel was four categories of instrumentation, as the 1994 panel had
concluded, with no disposition of any other categories. Dr. Genco
replied that he hoped new guidelines had been established in regard to
classification but that more information is needed before classification
begins. He adjourned the meeting at 4:30 p.m.

**Panel Participants**

**November 4, 1997**

**Acting Chair**

Dr. Robert J. Genco

**Executive Secretary**

Ms. Pamela Scott

**Panel Members**

Dr. Janine E. Janosky

Dr. Mark D. Patters

Dr. Willie L. Stephens

**Panel Consultants**

Dr. John Brunski

Dr. James Drummond

Dr. Leslie Heffez

Dr. George McCarthy

Dr. Andrea Morgan

Dr. Elizabeth Diane Rekow

**Consumer Representative**

Dr. Donald S. Altman

**Industry Representative**

Mr. Floyd Larson

**Guests**

Dr. Glenn Clark

Dr. Eric Furst

Dr. Barry Hendler

**FDA Participants**

Dr. Robert Betz

Dental Officer

Dental Devices Branch

Ms. Angela Blackwell

Biomedical Engineer/Dental Reviewer

Dental Devices Branch

Dr. Susan Runner

Branch Chief

Dental Devices Branch

Dr. Sandra Shire

Dental Officer

Dental Devices Branch

Mr. Timothy A. Ulatowski

Division Director

Division of Dental, Infection Control, and General Hospital Devices

**OPEN SESSION\--November 4, 1997**

Acting Panel Chair Dr. Robert Genco opened the meeting at 8:35 a.m. and
introduced Executive Secretary Pamela Scott. Ms. Scott introduced the
panel members and read the conflict of interest statement for the
November 4 and 5 sessions, noting that matters pertaining to Drs. Genco,
Rekow, Heffez, Morgan, and Drummond had been considered but deemed to
pose no conflict of interest. Waivers for Drs. Janosky and McCarthy had
also been granted, allowing their full participation. Ms. Scott also
read an appointment to temporary voting status for Drs. Rekow, Morgan,
Drummond, and Heffez.

**OPEN PUBLIC HEARING**

Dr. Genco opened the floor for the open public hearing on
reclassification of endosseous dental implants. There were no new
requests to speak.

**FDA PRESENTATION**

Dr. Susan Runner, Chief of the Dental Devices Branch, gave a brief
regulatory history of endosseous dental implants, which were originally
recommended as class III devices in 1976 and thus classified in 1987 on
the basis on insufficient evidence of safety and efficacy. Subsequently
a petition was lodged for down-classification to class II, which caused
a panel decision more than five years ago to classify the uncoated screw
type implants in the anterior mandible as class II devices and all
others as class III. Since then, as such implants have become the
acceptable standard of care, the FDA is reconsidering the classification
of some subgroups and asked the panel to consider the information, ask
questions, and state what levels of scientific evidence are necessary to
allow a reclassification of various subtypes of endosseous implants.

Dr. Angela Blackwell, a biomedical engineer in the Dental Devices
Branch, presented two versions of a grid showing implant types and
indications. She listed the 15 different types of implants and described
their physical characteristics and discussed the six indications to be
considered. She noted that not all implant types are for all indications
and that some would not be addressed at the panel meeting, such as use
of implants with other devices. She asked the panel to mention any
specific indications that should be added for future consideration.

Dr. Blackwell listed four questions for the panel to consider in its
deliberations. She noted that dental implant accessories would not be
considered because the FDA is proposing to reclassify all dental implant
accessories used in the mouth for less than one hour as class I exempt
devices.

**INDUSTRY PRESENTATIONS**

**Dr. Alan Balfour** of **Balfour Medical Consulting** discussed the
mechanical aspects of dental implants. He outlined the standards for
functional and structural testing in the 510 (k) process and the
questions such standards are designed to answer. He compared the
mechanical properties of bone versus titanium and how standards are set
by determining the normal maximum occlusal force and adding a defined
safety factor. Dr. Balfour described what structural tests should be
done to evaluate a new implant design, such as compressive bending,
torsional loading, compressive fatigue, and bending moments, and
discussed how testing standards have been developed.

**Dr. Charles** **Babbush** of the **Dental Implant Manufacturers
Association** spoke on the basis of his 20 years of experience with
implant reconstruction, as well as consultation with other clinicians,
to strongly urge recommendation of class II status for all endosteal
osseo-integrated implants: blades, cylinder, and threaded. He based his
recommendation on their wide acceptance and use, favorable risk/benefit
ratio, and substantiation with life table analysis. Dr. Babbush observed
that if there is a divergence in reclassification of these systems, a
number of practitioners and patients will be put at risk because
threaded implants cannot and will not produce acceptable levels of
success in some patients. He added that one-half of the edentulous
population cannot function with conventional removable prosthetic
appliances and that those with severe advanced atrophy would be
helpless. While recognizing the professional responsibility to protect
the public, he also noted the professional responsibility to demonstrate
proven efficacy and sufficient benefit/risk rations so that such
procedures can be used when other routine dental procedures are not
acceptable forms of treatment.

**Mr. Bill Knox** and **Dr. Freimut Vizathum** of **Friatec** described
their company and outlined the process that occurs after tooth
extraction in which bone atrophy can lead to a cascade of pathologies.
Dr. Vizathum described implant materials used by his company such as
titanium and ceramics, as well as factors to be considered in the
procedure such as implant surface, surgical concept, application system,
and load protection. In conclusion, he recommended down-classification
for endosseous implants because of the high potential benefits to a
large patient population.

**Dr. Gerald Marlin** of **Universal Implant Systems, Inc**. asked the
panel to address implant abutments from a regulatory perspective, saying
that they are over-regulated with far-reaching effects on the
profession, the industry, and the public. He discussed problems with the
current regulatory classifications of abutments and their potential
ramifications and summarized clinical and industry experience that
justify reclassification on the basis of proven safety and efficacy. Dr.
Marlin proposed that dental implant abutments be expeditiously
classified as separate devices in class I or class II or be left alone
as preamendment devices. He urged consideration be given to making these
products class I exempt on the basis of the extensive positive clinical
experience of the last 14 years. In reply to panel questioning, he
stated that an abutment could hypothetically cause an implant to fail,
but it would be very rare.

**Dr. Victor Sendax** of **MDIC Management, Inc**. discussed a different
approach to implants, focusing on one-stage with immediate loading
implants. These are ultra-small, biocompatible titanium transitional
devices or mini-implants to support a replacement bridge or prosthesis
while conventional implants are being integrated. He stated that data
show that these mini-implants are doing what they are supposed to do
safely and effectively, and he recommended that the devices, well
functioning on a limited basis, be cleared. In reply to panel
questioning on whether placement and/or loss of a mini-implant could
prevent a permanent implant, he replied that he had never encountered
such in his experience.

**Dr. Hessam Nowzari** of **Sargon Dental Implants** gave an overview of
the Sargon immediate load implant, which he described. He summarized
clinical, histological, immunological, and microbiological features of
the implant and concluded that the Sargon tooth replacement system seems
to be the most advanced treatment modality available at present and that
this implant constitutes a valuable treatment modality in optimizing the
potential for healing.

**Dr. Charles Weiss** of **Oratronics, Inc**. compared the root form and
blade implants, noting that if the panel chooses to reclassify root
forms because they have been proven safe and effective for intended use,
they should also reclassify blade forms that have produced equal and
often superior data. He cited clinical trials that show good results in
helping prevent the serial loss of natural teeth often associated with
removable partial dentures and in being remarkably free of long-term
harmful effects. He noted that blade implants were suitable for use in
100% of patients with available bone suitable for root form implants and
in 90% of those not suitable for root forms. Dr. Weiss supported
reclassification for both root form and uncoated blade implants (with or
without impressed interface textures) based on their record of safety,
effectiveness, and quality. **Dr. Irene Hermann** of **Nobel Biocare**
discussed variables such as implant material, design, surface, patient
site, prosthesis, and surgery. She discussed permanent and temporary
implants made of titanium and non-titanium materials for long or
short-term placement. She gave statistics on the Brandemark System
Implant and its success rates for various indications and techniques.
She recommended down-classification to class II for all screw-shaped
temporary and zygomatic implants, based on their promising patient
benefits. Dr. Hermann noted a special training program for implant
placement, saying such could be a special condition for
reclassification.

**Mr. Mike Keehoe** of **Innova Corporation** described the company's
Endopore Dental Implant System and gave its clinical history. **Dr.
Pilliar** described the geometry of its system design, noting its porous
and textured metal surface. **Dr. Paul Armstrong** gave clinical results
from various studies and summarized reported cumulative success rates to
support reclassification to class II based on the shape, material, size,
surgical technique, clinical experience and reasonable assurance of
safety and effectiveness. He strongly recommended that coated cylinder
porous metallic implants be reclassified to class II. In reply to panel
questioning, he did not specify a classification for abutments.

**Mr. Kermit Stott** of **Sulzer/Calcitek** urged that endosseous HA
coated cylinders and screws be reclassified as class II, noting that
special controls can help ensure safety and efficacy of class II
devices. He thought the design features were well known and safety and
efficacy demonstrated sufficiently to warrant such reclassification.
**Dr. Bill Wagner** noted that the manufacturing technique can help
determine the quality of HA coating, and that the coated hip implants
that are classified as class II use the same coating as dental implants
He recommended at least three special controls on the HA coating content
and characteristics for class II categorization and suggested that other
HA coatings be classified as class III. In reply to panel questioning on
when failures occur, he said those that happen generally occur within
the first year.

**Dr. Don Kennard** of **Steri-Oss, Inc**. cited the extensive history
of safety and efficacy of endosseous dental implants and said that
manufacturers need additional time to provide data arguing for fewer
controls. He suggested that the panel review ongoing studies since its
1991 meeting, including the American Dental Association acceptance of
various types. He encouraged the FDA to allow time for manufacturers to
submit the same data as that presented to the ADA in the
reclassification consideration and suggested that the recommendations be
as broad as possible. In reply to panel questions on abutments as a
separate subcategory, he suggested that material type and application be
considered and that abutments be given separate consideration but
perhaps not separate classification.

**Mr. Bill Ryan** and **Dr. David Cochran** of **Straumann USA**
described the company's ITI Dental Implant System. They described their
products' features and ITI implant types, as well as the surface
characteristics. They provided in vitro testing results, fracture rate
analysis, scientific support, peer reviewed studies, and clinical
results for the ITI dental implant system and concluded that it has a
consistently high success rate over all anatomical locations, that the
safe and effective use of the ITI hollow and solid titanium plasma
sprayed implants has been confirmed by scientific literature, and that
the FDA has sufficient general and special controls to provide
reasonable assurance of safety and efficacy. They recommended on the
basis of clinical and nonclinical results of their implant system that
uncoated and titanium plasma sprayed root form titanium dental implants
be reclassified as class II devices. In reply to panel questioning, they
acknowledged differences between the nonsubmerged and submerged dental
implants but thought them not different enough to require separate
classification. They also argued against subcategorizing solid cylinders
from solid screws and against using labeling restrictions based on
anatomical location.

**Dr. Richard Caudill** of **Implant Innovations, Inc**., reported
clinical data from ongoing PMA trials on his company's threaded cylinder
implants. After reviewing statistics and demographics from the
multicenter, multisite trial and listing implantation criteria, he
summarized safety and efficacy results, saying that no medical events
indicate biocompatibility problems and that there is adequate indication
of success in all locations. He suggested that anatomical location
restrictions be made on the merit of the individual device and that the
panel should require adequate research data for future implant systems.
In response to panel questioning, he noted that all of his company's
implants are solid implants.

**Dr. Kenneth Burrell** of the **American Dental Association** (ADA)
invited the panel to use the ADA's Acceptance Guidelines on Endosseous
Implants. He listed in detail what the ADA required for product
information, quality controls on manufacturing processes, details on
physical properties, and proof of safety and efficacy through data from
two independent prospective clinical studies. He stated that major ADA
concern centered on the design of clinical trials and the specificity of
clinical data. Instead of using various categories and subgroups, the
ADA chose to define the study population so that the subjects would have
implants in less favorable locations; thus, clinical success could be
extrapolated to more favorable locations. He discussed the model for the
clinical studies, evaluation techniques and standards, and criteria.
Manufacturers must describe restorative components used, but acceptance
is issued only to implant and placement technique. Companies can
petition for acceptance of similar product types, but significantly
different implants must have separate clinical trials. Recognition of
national and international materials standards for dental implants would
lessen the need for clinical trials, but until such recognition each
implant system must be evaluated separately to ensure safety and
efficacy. In reply to panel questioning, Dr. Burrell said that some 20%
of the 20 million totally edentulous patients in the United States have
lost so much bone they cannot be served by dental implants.

**OPEN COMMITTEE DISCUSSION**

In discussing the categories or groups of devices, the panel first
suggested dividing endosseous implants into root form and blade
subgroupings, with root forms further subdivided into porous for
biological fixations, other coatings, and noncoated types, and blade
form divided into coated (porous and nonporous) and noncoated types. Dr.
Runner suggested that another perspective would be to look at types of
implants and indications and decide what degree of regulatory control is
necessary, pulling out any other categories needing other degrees of
control. From that perspective, the panel suggested four subcategories
with clear differences for indications: root form, blade, special
retention features, and temporary.

The panel recommended that the FDA should not continue to consider
implant location in the oral cavity as a component of the device's
indication for use.

The panel recommended that the FDA should classify abutments separately
from the implant fixture because of practical concerns such as the
number of combinations and the different array of problems. There was
disagreement from the manufacturing representatives present about
whether abutments should or should not be used with implants produced by
other companies.

The panel asked for additional information before the next panel meeting
on the rationale and justification data for special indications or uses
like bone ingrowth or healing. Panel members also wanted more data on
when failures occur and what kinds of failure occur at particular
stages. Life table analyses and safety and efficacy data were requested
on the four subgroups, as well as a comparison of coated versus uncoated
implants and a study of ceramic versus metal implants.

Executive Secretary Pamela Scott noted that the next panel dates would
be January 12, 13 and possibly 14, 1998.

**OPEN PUBLIC HEARING**

Dr. Genco opened the session on classification of intra-oral appliances
for the treatment of obstructive sleep apnea and snoring by introducing
the invited guests, Drs. Barry Hendler, Eric Furst, and Glen Clark. He
opened the floor for presentations by professional organizations.

**Dr. Martin Scharf** of the **Tri-State Sleep Disorder Center** stated
that snoring is not the same as sleep apnea, but that snoring is still a
problem in that the sleep of snorers requires greater effort and is not
as refreshing as regular sleep. He noted problems with many of the
medically approved cures for snoring and commented on the number of
commercially available devices for snoring. He reported some success his
patients had experienced using a commercial device called SnoreBan but
also some reports of side effects and associated problems. He asked for
clinical data on the device. FDA representatives noted that SnoreBan is
an illegally marketed device subject to seizure.

**Dr. Sandra Shire, Dental Officer of the FDA Dental Devices Branch**,
noted that this category of products is designed to treat snoring and
mild-to-moderate obstructive sleep apnea by increasing the amount of
space in the patient's airway, thereby decreasing air turbulence. She
noted that apnea may occur in 35% of snorers. This group of products
includes mandibular repositioners, tongue retaining devices, and palatal
lifting devices, all of which are currently unclassified. Prescription
labeling is required for all intra-oral devices in this category. FDA
review of these appliances is required prior to marketing; during this
review, the FDA examines the extent of claims. The Agency has
recommended that products that claim to treat obstructive sleep apnea
include clinical data demonstrating effectiveness. She asked the panel
to consider whether prescription labeling is appropriate and what
labeling considerations should apply if over-the-counter use is deemed
appropriate, and she read questions for the panel to consider.

**Dr. Charles Berman** spoke on behalf of **Dr. Hillerson**, a maker of
anti-snoring devices. He suggested that snoring devices be
down-classified to class I and labeled only for anti-snoring use. He
thought the panel should view this as a decision of conscience, to make
it easy for makers to bring devices for snoring relief to the market and
to make it easy for snorers to obtain relief.

**Dr. Daniel Loube** of the **American Sleep Disorders Association
(ASDA)** spoke about the medical sequelae of obstructive sleep apnea,
which include hypertension, coronary artery disease, hyperglycemia, and
stroke. He discussed the treatment options and responses of patients
with various respiratory distress indexes (RDIs) and the practice
parameters for using oral appliances for snoring and sleep apnea. He
noted that the use of oral appliances is not perfected for sleep apnea
and that side effects such as gagging, salivation, or TMJ symptoms occur
in as much as 25% of all users. He recommended that use of oral
appliances be considered with respect, that dentists and doctors should
be involved in the decision, and that subjective responses and analyses
are inadequate.

The open meeting was adjourned for the day at 4:40 p.m.

**Panel Participants**

**November 5, 1997**

**Acting Chair**

Dr. Robert J. Genco

**Executive Secretary**

Ms. Pamela Scott

**Panel Members**

Dr. Janine E. Janosky

Dr. Mark D. Patters

Dr. Willie L. Stephens

**Panel Consultants**

Dr. James Drummond

Dr. Leslie Heffez

Dr. Andrea Morgan

Dr. Elizabeth Diane Rekow

**Consumer Representative**

Dr. Donald S. Altman

**Industry Representative**

Mr. Floyd Larson

**Guests**

Dr. Glenn Clark

Dr. Eric Furst

Dr. Barry Hendler

**FDA Participants**

Dr. Robert Betz

Dental Officer

Dental Devices Branch

Ms. Angela Blackwell

Biomedical Engineer/Dental Reviewer

Dental Devices Branch

Dr. Susan Runner

Branch Chief

Dental Devices Branch

Dr. Sandra Shire

Dental Officer

Dental Devices Branch

Mr. Timothy A. Ulatowski

Division Director

Division of Dental, Infection Control, and General Hospital Devices

**OPEN SESSION\--November 5, 1997**

Acting Panel Chair Dr. Genco opened the meeting at 8:10 a.m. Executive
Secretary Pamela Scott reiterated the conflict of interest statement
from the preceding day's session.

**FDA PRESENTATION**

Dr. Sandy Shire, Dental Officer in the Dental Devices Branch, gave an
overview of the issue of classifying intra-oral appliances for the
treatment of obstructive sleep apnea and snoring. She noted that snoring
is a social and medical problem and that 35% of snorers have sleep
apnea. Almost all patients with obstructive sleep apnea snore unless
they have had surgery. Apnea that lasts more than 10 seconds or occurs
more than seven to ten times per hour is considered pathological. She
noted that there are surgical and medical approaches to treatment of
snoring and that intra-oral devices are reviewed under the 510 (k) and
PMA processes, depending upon the extent of claims. One question for
panel consideration was whether these devices should continue to be sold
by prescription only or should be made available for over-the-counter
(OTC) use. She reported three main types of devices cleared for the
market: the tongue retaining devices that increase airway patency, the
palatal lifting devices that lift the soft palate, and the mandibular
repositioning devices that move the mandible forward. Dangers or side
effects include musculoskeletal problems with the mandible and TMJ
complications. She noted that 25-50% of snorers have at least some
measure of apnea and 99% of those with apnea also snore, unless they
have had surgery to correct it. Some snorers have upper airway
resistance syndrome, in which they do not sleep well but they do not
have apnea.

Executive Secretary Pamela Scott introduced the panel and guests Drs.
Glenn Clark, Eric Furst, and Barry Hendler.

Guest speaker **Dr. Barry Hendler** of the **University of Pennsylvania
Medical Center** opened his presentation by noting two issues: primary
snoring and obstructive sleep apnea. He remarked that people who snore
can be relatively healthy but those with obstructive sleep apnea have
complications and a potentially life-threatening disease. Mild sleep
apnea is defined as a respiratory distress index (RDI) of less than 20;
moderate as an RDI of 20 to 40, and severe as an RDI of 40 or more,
showing oxygen desaturation in varying degrees. He reviewed the practice
parameters presented by the American Sleep Disorders Association and the
American Board of Sleep Medicine clinical guidelines, emphasizing that
while the objective of treating snoring without apnea is just to
eliminate snoring, for obstructive sleep apnea the objective is to
resolve the symptoms and normalize the apnea and oxygen saturation.
Moderate to severe OSA should be treated with a trial of continuous
positive airway pressure (CPAP), which can cure most moderate apnea, but
patients often refuse to comply with the treatment. Oral appliances are
recommended for those with mild to moderate apnea who refuse CPAP;
surgery is also successful. The side effects of oral appliances,
however, make it important for the fitting to be done by professionals.
He noted the lack of randomized clinical studies on sleep appliances and
warned that the mere removal of snoring has the potential for danger for
those with undiagnosed sleep apnea.

**Dr. Dennis Bailey** spoke on behalf of the **Sleep Disorders Dental
Society (SDDS)**, saying that SDDS feels strongly that they should work
together with the ADA on the issue of oral appliances. He outlined the
architecture of NREM and REM sleep, noting that delta slow wave sleep
during NREM , which is lost during sleep apnea, is critical to health.
He said that apnea is a medical, not a dental disorder, with clinical
signs and physiologic sequelae. He noted the variability of
effectiveness of oral appliances and CPAP and reviewed the ASDA clinical
guidelines for treatment. He discussed the types of appliances, showed
pictures, and explained how they function. He concluded that oral
appliances are effective, based on changes in patients' apnea index and
RDI. They are more effective for snoring than for apnea, which they do
not eliminate but they do improve. He discussed contraindications such
as central sleep apnea, TMJ disorder, inadequate dental status, and lack
of motivation, and he listed possible side effects, such as excessive
salivation, dry mouth, soft tissue irritation, or TMJ discomfort. He
noted the importance of dentists working with doctors to ascertain those
patients with optimal outcomes. The mission of SDDS is to develop a
certification process for dentists using and making these appliances. He
noted that soft palate lifters are no longer considered effective and
suggested splitting the temporomandibular appliances into fixed, mobile,
and adjustable.

**Dr. Steven Burton** and **Mr. Robert Hezlep** of **EPM Systems**
stated that snoring and apnea are related but separate problems. They
are producers of an FDA-accepted device for snoring. They noted that the
vast majority of snorers just snore, and that restricting avenues for
relief affects some 50 million people. They stated that snoring is
improved and often eliminated in almost all patients who use oral
appliances, which are the first-line therapy for primary snoring from
the ASDA position. Mr. Hezlep stated that snoring alone does not have
high enough diagnostic accuracy to serve as a useful screening test for
apnea. They proposed a classification of class II devices for apnea and
class I over-the-counter devices for snoring or class II custom-made
devices for snoring. They suggested that patients should be cautioned
about danger signs such as excessive daytime sleepiness, episodes of
holding breath during sleep, high blood pressure, stroke, dentures, and
history of TMJ or jaw pain and should be advised to consult their doctor
about using the device.. Symptoms suggesting the need for medical care
would include excessive daytime sleeping, waking one's self from a
snore, sweating while sleeping, and morning headaches. They suggested a
continuum of problems that ranged from no snoring, to periodic snoring
affecting 28 million, to chronic snoring affecting 35 million, to upper
airway resistance syndrome, to mild sleep apnea affecting 5 million, to
moderate or severe sleep apnea affecting 10 million, to hypoventilation.

In response to panel questions, Dr. Shire of the FDA replied that the
FDA could make a regulatory suggestion such as class II with OTC or
prescription distribution so that the Agency could review the labeling.
A video and or education pamphlet and money back guarantee were also
suggested. It was also noted in reply to panel questions that sleep
apnea is very rare in children but snoring is not.

**Mr. Gary Meade** and **Mr. Stephen Brown** of **DISTAR, Inc**.,
discussed the Snore Guard and TheraSnore oral appliances made by Mr.
Brown's father. These are adjustable prefabricated mandibular
positioning devices. Their experience has been that this device is safe
and effective in the treatment of snoring with only minor side effects
and that such devices do not require special controls. They recommended
a classification of class I for OTC or at most class II OTC use to
permit Agency review of device labeling.

There was some concern expressed by the panel about the potential for
lower anterior flaring with long-term use of oral devices.

**Mr. Bob Lezia** of **Great Lakes Orthodontics** spoke about his
company's experience with the ClearWay device. He suggested that the
three types of oral appliances be kept separate, and he noted that
mandibular repositioning devices differ among themselves. He recommended
that each appliance supply studies to show results, and he thought OTC
availability could be dangerous. He suggested TMJ, periodontia and
edentulism be contraindications for use and suggested randomized
clinical trials of two groups with pre-use and post-use polysonographs,
a quality of life assessment questionnaire, and compliance data. He
cited study results on the ClearWay device, noting that these appliances
are FDA approved and custom-made from a mold but manufactured en masse.

In discussing the questions presented by the FDA, the panel suggested
three subclasses of oral appliances: mandibular repositioners, tongue
retaining devices, and palatal lifters. They had significant concern
about designs not permitting oral breathing and recommended that design
features should include adequate space for oral breathing and should
prevent incisor flaring in those under orthodontic care. Recommended
warnings included not using the device (1) in patients with edentulism,
(2) with removable dentures, (3) in patients with periodontal disease,
(4) with loose teeth or tooth mobility, (5) in growing or not fully
grown individuals, (6) with previous TMJ disease or discomfort, such as
jaw clicking, crepitation, tooth pain or jaw pain, (7) in patients under
orthodontic care, and (8) if there are signs of incisor or periodontal
flaring. Use should be discontinued if pain develops in the jaw muscles.

The panel considered discussing prescription use versus over-the-counter
use strictly for snoring claims. **Dan Loube** of the **ASDA** objected
to splitting the indications, saying that snoring should be treated as a
medical problem and that all treatments for snoring are applied for
sleep apnea and patients cannot assess the outcome. The panel decided to
discuss the devices for prescription use only.

The panel then filled out the general device classification
questionnaire for the generic group of removable intra-oral devices for
the treatment of snoring and obstructive sleep apnea. The panel agreed
that the devices were not life-sustaining or supporting. After some
discussion and clarification, they agreed that the devices are not of
substantial importance in preventive impairment of human health and that
they do not present a potential unreasonable risk of illness or injury.
They felt that general controls were not sufficient to provide
reasonable assurance of safety and effectiveness and that special
controls were required. They agreed there was sufficient information to
establish special controls, which included testing guidelines and the
specific warnings listed above. They restricted sale, distribution, or
use to prescription use only. As supplemental data, they identified the
following risks to health: sore teeth and gums, TMD pain and dysfunction
syndrome, flaring of the lower anteriors, and obstruction of breathing.
As specific hazards to health, they identified painful gingival sores
and long-term orthodontic effects such as generalized tooth loosening
from the pressure induced by the device; TMD from poor adjustment and
the orthopedic effect; oral obstruction from the lack of airspace, and
interference with normal orthopedic development from the rigidity of the
appliance. The panel recommended class II classification on the basis of
presentations to the panel by industry and professional associations, of
information received, of clinical experience, and judgment. The
appropriate materials standards should be applied to the devices.

It was clarified that a reclassification petition would be required to
obtain over-the-counter availability for the devices. Pamela Scott
announced that the voting members of the panel were Drs. Rekow, Morgan,
Drummond, and Heffez. A motion was made and seconded to classify the
devices as class II. It was unanimously approved.

The panel asked to see studies on snoring that would present randomized,
controlled trials comparing devices or at least blind scoring of the
data. Snoring should be measured by microphone and oximetry and by
sleepiness questionnaires. The panel recognized that the FDA is not the
National Institutes of Health and that some studies are already done,
but members would like clinical data on snoring and obstructive sleep
apnea showing reasonable outcomes, power calculations, and reasonable
controls.

The panel was asked to comment on the possibility of OTC use for snoring
indications only. Some panel members thought it reasonable to consider
OTC use for snoring if devices were properly labeled and presented with
sufficient studies. Other members remained concerned about masking cases
of apnea. Still others had concerns but felt the matter should be looked
into with more information available, such as long-term data on tooth
movement over time. They also suggested adding patient educational
methods such as a phone-in information line as backup.

Dr. Genco thanked the FDA staff and panel members, as well as invited
guests and adjourned the panel at 1:00 p.m. On behalf of the FDA, Pamela
Scott thanked Dr. Genco for serving as acting chair.

I certify that I attended the Open Session of the Dental Products Panel
Meeting on November 3-5, 1997, and that this summary accurately reflects
what transpired.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Pamela Scott

Executive Secretary

I approve the minutes of the meeting as recorded in this summary.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Robert J. Genco, M.D.

Acting Chair

Summary minutes prepared by Aileen M. Moodie

9821 Hollow Glen Pl.

Silver Spring, MD 20910

301-587-9722