Guidance for Industry and FDA Staff 
 
Dental Handpieces - Premarket 
Notification [510(k)] Submissions 
 
 
Document issued on:  May 2, 2007 
 
This guidance supersedes Guidance Document on Dental Handpieces 
issued July 1995  
 
 
 
 
For questions regarding this document contact Kevin Mulry at 240-276-3684 
or via email at kevin.mulry@fda.hhs.gov.  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Dental Devices Branch 
Division of Anesthesiology, General Hospital,  
Infection Control, and Dental Devices 
Office of Device Evaluation 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration 
to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments 
may be submitted to http://www.fda.gov/dockets/ecomments.  When submitting comments, 
please refer to the exact title of this guidance document.  Comments may not be acted upon 
by the Agency until the document is next revised or updated.   
Additional Copies 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ode/guidance/556.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request 
to 240-276-3151 to receive a hard copy.  Please use the document number (556) to 
identify the guidance you are requesting. 
 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
1.  Introduction.............................................................................................................1 
The Least Burdensome Approach...........................................................................1 
2.  Background.............................................................................................................2 
3.  The Content and Format of an Abbreviated 510(k) Submission............................2 
4.  Scope.......................................................................................................................5 
5.  Device Description...........................................................................6
6.  Risks to Health........................................................................................................7 
7.  Performance Testing...............................................................................................7 
8.  Electrical Safety and Electromagnetic Compatibility.............................................8 
9.  Biocompatibility..............................................................................9
10.  Labeling..................................................................................................................9 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
 
Dental Handpieces - Premarket 
Notification [510(k)] Submissions 
 
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.  You can use an alternative approach if the 
approach satisfies the requirements of the applicable statutes and regulations.  If you 
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
 
1.  Introduction 
FDA has developed this guidance document to assist industry in preparing premarket 
notification submissions (510(k)s) for dental handpieces intended to prepare dental 
cavities for restorations, such as fillings, and for cleaning teeth. (21 CFR 872.4200).  This 
guidance supersedes the document entitled, Guidance Document on Dental Handpieces 
issued July 1995.  It updates the references and clarifies the recommendations. 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe need to 
be addressed before your device can be marketed.  In developing the guidance, we 
carefully considered the relevant statutory criteria for Agency decision-making.  We 
also considered the burden that may be incurred in your attempt to follow the guidance 
and address the issues we have identified.  We believe that we have considered the 
least burdensome approach to resolving the issues presented in the guidance 
document.  If, however, you believe that there is a less burdensome way to address the 
issues, you should follow the procedures outlined in the A Suggested Approach to 
Resolving Least Burdensome Issues document.  It is available on our Center web 
page at http://www.fda.gov/cdrh/modact/leastburdensome.html. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.   
 
  1 Contains Nonbinding Recommendations 
 
2.  Background 
A manufacturer who intends to market a device of this generic type must conform to the 
general controls of the Federal Food, Drug, and Cosmetic Act (the act), including the 
premarket notification requirements described in 21 CFR 807 Subpart E, and obtain a 
substantial equivalence determination from FDA prior to marketing the device.  (See also 
21 CFR 807.81 and 807.87). 
This guidance document identifies the classification regulations and product codes for 
dental handpieces (refer to Section 4.  Scope).  In addition, other sections of this 
guidance document provide additional information to manufacturers on addressing risks 
related to these devices in premarket notifications (510(k)s).  
This document supplements other FDA documents regarding the specific content 
requirements of a premarket notification submission.  You should also refer to 21 CFR 
807.87, the guidance, Format for Traditional and Abbreviated 510(k)s1and the section 
of CDRHs Device Advice, How to Prepare a 510(k) Submission.2
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating 
Substantial Equivalence in Premarket Notifications; Final Guidance,3 a 
manufacturer may submit a Traditional 510(k) or has the option of submitting either an 
Abbreviated 510(k) or a Special 510(k).  FDA believes an Abbreviated 510(k) provides 
the least burdensome means of demonstrating substantial equivalence for a new device, 
particularly once FDA has issued a guidance document addressing that device.  
Manufacturers considering certain modifications to their own cleared devices may lessen 
the regulatory burden by submitting a Special 510(k). 
3.  The Content and Format of an Abbreviated 510(k) 
Submission  
An Abbreviated 510(k) submission must include the required elements identified in 21 
CFR 807.87, including the proposed labeling for the device sufficient to describe the 
device, its intended use, and the directions for its use.  In an Abbreviated 510(k), FDA 
may consider the contents of a summary report to be appropriate supporting data within 
the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you include a 
summary report.  The report should describe how this guidance document was used 
during the device development and testing and should briefly describe the methods or 
tests used.  We recommend that you also include a summary of the test data or 
description of the acceptance criteria applied to address the risks identified in this 
document, as well as any additional risks specific to your device.  This section suggests 
information to fulfill some of the requirements of 21 CFR 807.87, as well as some other 
items that we recommend you include in an Abbreviated 510(k). 
                                                 
1 http://www.fda.gov/cdrh/ode/guidance/1567.html. 
2 http://www.fda.gov/cdrh/devadvice/314.html. 
3 http://www.fda.gov/cdrh/ode/parad510.html. 
  2 Contains Nonbinding Recommendations 
 
 
A.  Coversheet 
The coversheet should prominently identify the submission as an Abbreviated 510(k) 
and cite the title of this guidance document. 
 
B.  Proposed labeling 
Proposed labeling should be sufficient to describe the device, its intended use, and the 
directions for its use.  (Please refer to Section 10. Labeling for specific information 
that should be included in the labeling for devices of the types covered by this 
guidance document.) 
 
C.  Summary report 
We recommend that the summary report contain: 
 
Description of the device and its intended use   
We recommend that you describe the performance specifications and, when 
appropriate, include detailed, labeled drawings of the device.  (Please refer to 
Section 5. Device Description for specific information that we recommend you 
include in the device description for devices of the types covered by this guidance 
document.)  You should also submit an indications for use enclosure.4
 
Description of device design 
We recommend that you include a brief description of the device design 
requirements. 
 
Identification of the risk analysis method 
We recommend that you identify the risk analysis method(s) you used to assess 
the risk profile, in general, as well as the specific devices design and the results 
of this analysis.  (Please refer to Section 6. Risks to Health for the risks to health 
generally associated with the use of this device that FDA has identified.) 
 
Discussion of the device characteristics  
We recommend that you discuss the device characteristics that address the risks 
identified in this guidance document, as well as any additional risks identified in 
your risk analysis.  
 
                                                 
4 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
  3 Contains Nonbinding Recommendations 
 
Description of the performance aspects 
We recommend that you include a brief description of the test method(s) you have 
used or intend to use to address each performance aspect identified in Sections 8-
10 of this guidance document.  If you follow a suggested test method, you may 
cite the method rather than describing it.  If you modify a suggested test method, 
you may cite the method but should provide sufficient information to explain the 
nature of and reason for the modification.  For each test, you may either (1) 
briefly present the data resulting from the test in clear and concise form, such as a 
table, or (2) describe the acceptance criteria that you will apply to your test 
results.5   
 
Reliance on standards 
If you choose to rely on a recognized standard for any part of the device design or testing, 
you may include either:  
  a statement that testing will be conducted and meet specified acceptance criteria 
before the device is marketed; or  
  a declaration of conformity to the standard.6   
 
Because a declaration of conformity is based on results from testing, we believe 
you cannot properly submit a declaration of conformity until you have completed 
the testing which the standard describes.  For more information, please refer to 
section 514(c)(1)(B) of the Act and the FDA guidance, Use of Standards in 
Substantial Equivalence Determinations.7  
 
If it is not clear how you have addressed the risks identified by FDA or additional risks 
identified through your risk analysis, we may request additional information about 
aspects of the devices performance characteristics.  We may also request additional 
information if we need it to assess the adequacy of your acceptance criteria.  (Under 21 
CFR 807.87(l), we may request any additional information that is necessary to reach a 
determination regarding substantial equivalence.)  
                                                 
5 If FDA makes a substantial equivalence determination based on acceptance criteria, the 
subject device should be tested and shown to meet these acceptance criteria before being 
introduced into interstate commerce.  If the finished device does not meet the acceptance 
criteria and, thus, differs from the device described in the cleared 510(k), FDA 
recommends that submitters apply the same criteria used to assess modifications to 
legally marketed devices (21 CFR 807.81(a)(3)) to determine whether marketing of the 
finished device requires clearance of a new 510(k). 
6 See Required Elements for a Declaration of Conformity to a Recognized Standard 
(Screening Checklist for All Premarket Notification [510(k)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html. 
7 http://www.fda.gov/cdrh/ode/guidance/1131.html. 
  4 Contains Nonbinding Recommendations 
 
As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 
510(k) that provides all of the information and data required under 21 CFR 807.87 and 
described in this guidance.  A Traditional 510(k) should include all of your methods, 
data, acceptance criteria, and conclusions.  Manufacturers considering certain 
modifications to their own cleared devices should consider submitting Special 510(k)s. 
 
In general, the discussion above applies to any 510(k).  The following is a specific 
discussion of how you should apply this guidance document to a premarket notification 
submission for dental handpieces. 
4.  Scope 
The scope of this guidance is limited to the Class I device described below, 21 CFR 
872.4200, which includes the product codes listed in the table below. 
 
21 CFR 872.4200 Dental handpiece and accessories 
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, 
or belt-driven, hand-held device that may include a foot controller for regulation of 
speed and direction of rotation or a contra-angle attachment for difficult to reach 
areas intended to prepare dental cavities for restoration, such as fillings, and for 
cleaning teeth. 
 
The scope of this guidance includes air-powered high speed handpieces, air-powered 
micromotors, contra-angle attachments, straight attachments and oscillating endodontic 
contra-angles.  This document also includes AC-powered handpiece systems that utilize a 
controller console, foot control, DC-powered micromotor, and lubricants.  
 
Procode  Device 
EBW  Controller, Foot, Handpiece and Cord 
EKX  Handpiece, Direct Drive, AC-Powered 
EFB  Handpiece, Air-Powered, Dental (includes lubricants) 
EFA  Handpiece, Belt And/Or Gear Driven, Dental 
EGS  Handpiece, Contra- And Right-Angle Attachment, Dental 
EKY  Handpiece, Water-Powered 
NYL  Handpiece, Air-Powered, Root Canal Irrigation 
 
The scope of this guidance does not include: 
  burs, mandrels, and other cutting attachments that are designed to be mounted in 
the chucks of handpieces (21 CFR 872.3240) 
  surgical bone saws and accessories (21 CFR 872.4120) 
 
  5 Contains Nonbinding Recommendations 
 
5.   Device Description  
We recommend you identify your device by regulation number and product code 
identified in Section 4. Scope and include a description of:  
  the principles of operation (i.e., the scientific principles behind how the device 
achieves its intended use) 
  any accessories that are to be used with the system. 
 
We recommend you provide information to show how the new device is both similar to 
and different from the legally marketed device.  Side by side comparisons, whenever 
possible, are desirable; for example, using a tabular format as shown below.  We also 
recommend that you describe how any differences may affect the comparative safety and 
effectiveness of your device. 
 
Table 1:  Device and Predicate Comparison Table 
Descriptive Information  Device   Predicate 
Indication for Use     
Device Design  i.e.,  operational   
modes, air/water ports, fiberoptics, 
 
dimensions, type of chuck, coupling 
dimensions, and accessories 
Composition of Materials    
including chemical composition of the 
 
waterlines and the patient-contacting 
portions of the device 
Technical Specifications  including   
chuck design, light intensity, bur 
extraction force, maximum air/water 
pressure, speed in rpms, and   
conformance with standards for 
shanks, coupling dimensions, and hose 
connections 
Lubricant  including legally-  
marketed lubricant (identify 510(k)), 
or chemical composition (including 
 
propellant, if applicable) with 
biocompatibility for lubricant not 
previously cleared through 510(k)  
  6 Contains Nonbinding Recommendations 
 
6.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with the 
use of dental handpieces, including lubricants and accessories, addressed in this 
document.  The measures recommended to mitigate these identified risks are given in this 
guidance document, as shown in the table below.  You should also conduct a risk analysis 
to identify any other risks specific to your device, and include the results of this analysis.  
If you elect to use an alternative approach to address a particular risk identified in this 
document, or have identified risks additional to those in this document, you should 
provide sufficient detail to support the approach you have used to address that risk. 
 
Table 2.  Risks and Mitigation Measures 
 
Identified Risk  Recommended Mitigation Measures 
 
Cross-contamination  Section 10. Labeling 
Device malfunction  Section 7. Performance Testing 
Electrical injury  Section 8.  Electrical Safety and 
Electromagnetic Compatibility 
Thermal injury  Section 7.  Performance Testing 
Section 10. Labeling 
Adverse tissue reaction  Section 9.  Biocompatibility (for each 
component and/or accessory) 
Improper use and maintenance  Section 10.  Labeling 
Electromagnetic interference  Section 8.  Electrical Safety and 
Electromagnetic Compatibility 
7.  Performance Testing 
We recommend that you evaluate your dental handpiece using the following FDA 
recognized standards or equivalent methods: 
  ISO 7785-1  High-speed Air Turbine Handpieces 
  ISO 7785-2  Straight and Geared Angle Handpieces 
  ISO 1797  Dental Rotary Instruments  Shanks 
  ISO 3964  Dental Handpieces  Coupling Dimensions 
  ISO 9168  Dental Handpieces  Hose Connections 
  ISO 9687  Dental Equipment  Graphical Symbols 
  ISO11498  Dental Handpieces: Dental Low Voltage Electrical Motors 
  7 Contains Nonbinding Recommendations 
 
  ISO 13294  Dental Handpieces  Dental Air-Motors 
 
In addition, we recommend that you describe: 
  components with dimensions, including engineering drawings 
  material composition of all components (include specifications or standards) 
  features, including air/water spray, fiberoptics, etc. 
  maximum operating air pressure in pounds per square inch (psi)    
  range of speed in rotations per minute (rpm) 
  coolant mechanism 
  testing conducted to demonstrate the effect of sterilization cycles on handpiece 
performance 
  type of chuck    
  bur release force in Newtons (N) 
  lubricant delivery system (i.e., spray can, pump) 
  types of connectors 
  shank length in millimeters (mm). 
 
If your dental handpiece is controlled by computer software, we recommend that you 
submit the information for software-controlled devices described in Guidance for the 
Content of Premarket Submissions for Software Contained in Medical Devices.8  
The information we recommend you submit is determined by the level of concern, 
which is related to the risks associated with software failure.  The level of concern for a 
device may be minor, moderate, or major.   
 
We recommend you demonstrate that the use of your device does not present a thermal 
hazard to the patient or the operator and describe the handpiece maintenance procedures 
to prevent overheating of the handpiece.  For example, you may wish to demonstrate that 
patient contacting portions of the device do not present a thermal hazard.  
8.  Electrical Safety and Electromagnetic Compatibility  
We recommend you demonstrate the electrical safety of your device by following the  
FDA-recognized standard below or equivalent methods:   
  IEC 60601-1:1988, Medical Electrical Equipment  Part 1: General requirements 
for safety 
We recommend you demonstrate the electromagnetic compatibility (EMC) of your 
device by following the recommendation of the FDA-recognized standard below or 
equivalent methods: 
                                                 
8 http://www.fda.gov/cdrh/ode/guidance/337.html
  8 Contains Nonbinding Recommendations 
 
  IEC 60601-1-2:1993, Medical Electrical Equipment  Part 1:  General 
requirements for safety  2. Collateral Standard:  Electromagnetic compatibility  
Requirements and test. 
9. Biocompatibility 
FDA recommends that you conduct biocompatibility testing as described in the FDA-
modified Use of International Standard ISO-10993, Biological Evaluation of Medical 
Devices Part-1: Evaluation and Testing,9 for limited contact with mucosal tissue. We 
recommend that you select biocompatibility tests appropriate for the duration and level of 
patient contact with your device.  For some devices, ISO 7405:1997, Dentistry  
Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry  
Test Methods for Dental Materials,10 may contain appropriate test methods.  If 
identical materials and identical material processing are used in a predicate device with 
the same type and duration of patient contact, you may identify the predicate device in 
lieu of providing biocompatibility testing. 
10. Labeling 
The premarket notification must include labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e).  The following suggestions are aimed at assisting you 
in preparing labeling that satisfies the requirements of 21 CFR Part 801.11  We 
recommend labeling include:    
  maximum speed in rotations per minute (rpm) 
  types of connectors 
  type of chuck 
  warnings about thermal hazards 
  maintenance requirements 
  warnings about lubricant hazards (spray can labeling and packaging should 
comply with other Federal requirements for transport and use). 
  operative speeds with gear reduction ratios. 
 
Dental handpieces are generally provided to the user as nonsterile devices.  Dental 
handpieces, including the micromotors, should be sterilized before the first use and 
between each patient use.  We recommend that you provide instructions for the user on 
how to sterilize the handpiece.  The instructions should include the method of 
sterilization and the cycle parameters, including the time, temperature and pressure.  We 
                                                 
9 http://www.fda.gov/cdrh/g951.html. 
10 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Detail.cfm?ID=1405  
11 Although final labeling is not required for 510(k) clearance, final labeling must comply 
with the requirements of 21 CFR Part 801 before a medical device is introduced into 
interstate commerce.  In addition, final labeling for prescription medical devices must 
comply with 21 CFR 801.109.  Labeling recommendations in this guidance are consistent 
with the requirements of Part 801. 
  9 Contains Nonbinding Recommendations 
 
recommend that the labeling and instructions for use of your device follow the 
recommendations of the FDA guidance:  Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: FDA Reviewer Guidance.12  In particular, the 
instructions for reprocessing13 should include details for the user on: 
  disassembly 
  cleaning 
  lubrication 
  sterilization14 
  drying 
  reassembly of the device 
  use of disposable sheathing for other portions of the system. 
 
Your 510(k) should identify the method that you used to validate the sterilization 
instructions.   
 
 
                                                 
12 http://www.fda.gov/cdrh/ode/198.pdf. 
13 See also Center for Disease Control and Preventions Guidelines for Infection 
Control in Dental Health-Care Settings  2003 for information about infection control 
in dental settings, http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm. 
14 http://www.fda.gov/cdrh/comp/589.pdf. 
  10