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Conference Number: PWXW9364565
Dental Devices Premarket 

Submissions

Malvina B. Eydelman, M.D., Director, 

Office of Health Technology 1 (OHT1)

Michael E. Adjodha, M.ChE., Acting Assistant Director

Restorative and Surgical Devices Team

Srinivas “Nandu” Nandkumar, Ph.D., Acting Director

Division of Dental Devices

Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 

(Office of Health Technology 1 (OHT1))

Office of Product Evaluation and Quality (OPEQ) 

Center for Devices and Radiological Health (CDRH)

October 2, 2019
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• Center for Devices and Radiological Health Reorganization

• Review Challenges and Opportunities for Dental Device 510(k) Submissions

– 510(k) Process Overview

– Dental Device Types

– Dental Device Submission Challenges

– Recommendations

– Resources

• Postmarket Overview

– Medical Device Reporting (MDR)

– Medical Device Safety Action Plan

– Safety Signal

– Market Withdrawals and Recalls

Agenda
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Objectives

During this webinar, the FDA will:

• Clarify the premarket submissions process, including what to 

submit and who to work with in the Center for Devices and 

Radiological Health’s Office of Product Evaluation and Quality 

(OPEQ)

• Explain information to include in a 510(k) submission in order to 

avoid refuse-to-accept (RTA) designation

• Clarify medical device reporting (MDR) requirements, including 

how to report and who should report (manufacturer, dentist, etc.)

• Discuss and answer questions from webinar participants about 

the premarket submissions for dental devices
Center for Devices and 

Radiological Health (CDRH):

Reorganization

Malvina B. Eydelman, M.D.

Director

Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

CDRH, FDA
6

Center for Devices and Radiological 

Health Reorganization

• CDRH conducted phased implementation of a Center 

reorganization.

• CDRH reorganization includes adopting a Total Product 

Lifecycle (TPLC) model and other efforts to streamline and 

improve efficiency and to support employees’ professional 

growth. 

• Implementation timeline: March 2019 - October 2019
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CDRH Structure prior to Reorganization

Super Office Office Division Branch Team Program/Staff
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CDRH Structure After Reorg Implementation

Super Office Office Division Branch Team Program/Staff
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Office of Product Evaluation and Quality

• OC, ODE, OIR, and OSB 

reorganized into one 

Super Office (OPEQ)

• OPEQ has 9 offices

Super Office Office Division Branch Team Program/Staff
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Office of Product Evaluation and Quality (OPEQ)

Super Office Office Division Branch Team Program/Staff
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Office of Ophthalmic, Anesthesia, Respiratory, 

ENT, and Dental Devices (OHT1)

Division of Dental Devices

Division Director (Acting):

Srinivas “Nandu” Nandkumar

Restorative and Surgical Dental Devices

Assistant Director (Acting):

Michael Adjodha

Implantable Dental Devices

Assistant Director: Vacant

Contact Lenses and Dry Eye Devices

Retinal and Diagnostic Devices

Glaucoma, Cornea, and Surgical Devices

Intraocular Lenses and Accessory Devices

Sleep Disorder Breathing Devices

Respiratory Devices

Ear, Nose, and Throat Devices

Anesthesia Devices

Office Director

Malvina B. Eydelman, M.D.

Chief Medical Officer Assistant Director Associate Director Associate Director for 

Operations

Division of Ophthalmic Devices

Deputy Director

Division of ENT, Sleep Disordered Breathing, 

Respiratory, and Anesthesia Devices

Deputy Director
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OPEQ Design Features

• Working in teams

 Team management approach

 Teams within and across divisions

• Common management chain for compliance, premarket 

and surveillance programs

• Division is the lowest organizational structure

• Empowering staff by driving decision-making to lowest 

appropriate level

• Emphasis on professional development & work-life 

balance
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Value Added for You

• Improving our internal processes, coordination 

and communication  more straightforward & 

streamlined interactions with CDRH

• Consolidating our structure  provides you with a 

“one stop shop” in many cases

• Creating a more agile organization  better 

response to changing regulatory needs and new 

technologies
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Value Added for You

• Ensuring more consistent policy application across 

OPEQ  easier for you to know what to expect

• Streamlining decision making  more informed 

interactions with CDRH staff

• Focus on professional growth and creating a better 

work-life balance for our employees  increased 

longevity of your points of contact within the 

organization due to reduced staff turn-over
Review Challenges and Opportunities for 

Dental Device 510(k) Submissions

Michael E. Adjodha, M.ChE.

Acting Assistant Director, 

Restorative and Surgical Dental Devices Team
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• Each person who wants to market in the U.S. a medical device intended for 

human use (for which a Premarket Approval application (PMA) is not required) 

must submit a premarket notification submission (510(k)) to FDA unless 

the device is exempt from 510(k) requirements of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act).

• The 510(k) pathway is the most common pathway to market for medical 

devices 

• A 510(k) is a premarket submission made to the FDA to demonstrate that the 

device to be marketed is as safe and effective, that is, substantially 

equivalent, to a legally marketed device (Section 513(i) of FD&C Act)

• For more details about how to prepare a 510(k) submission, see the relevant 

guidance document:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditionaland-abbreviated-510ks

Background
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510(k) Process Overview

The FDA Review Clock:

• Does not begin if there is a user fee or eCopy issue.

• Starts when there are no user fee or eCopy issues.

• Pauses when submission is on Additional Information (AI) hold.

• Resumes upon receipt of response to AI Letter.

• Stops after recommendation letter is issued.

510(k) Review Timeframe in FDA Days:*

• TRADITIONAL: 90

• ABBREVIATED: 90

• SPECIAL: 30

• THIRD PARTY:30 

*FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request.
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Dental Device Types

Found in Part 872 of Title 21 of the Code of Federal Regulations (21 CFR 872)

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=872

• Diagnostic Devices

– For example, caries detection device, radiography devices, etc.

• Prosthetic Devices

– For example, C&B alloys and resins, composite resins, amalgam, cements, endosseous 

implants, root canal resins, bone grafting materials, impression materials, denture resins, 

endodontic materials, etc.

• Surgical Devices

– For example, dental handpieces, ultrasonic scalars, bone plates, etc.

• Therapeutic Devices

– For example, orthodontic appliances and treatment planning software, anti-snoring devices, etc.

• Miscellaneous Devices

– For example, curing lamps, dental operative units, dental ceramics, prophy paste, toothbrushes, 

etc.
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General Observations

• Predominate workload involves 510(k) submissions but also includes 

Pre-Submissions, Premarket Approval (PMA) supplements and 30-

day notices, 513(g) submissions, and Investigational Device 

Exemptions (IDEs) 

• High volume of 510(k) submissions

– Significant percentage are from small or foreign manufacturers

• High first cycle Refuse-to-Accept (RTA) rate (81%) in CY 2018

• Average 510(k) clearances: 240+/year, down 10% in CY 2018

200

210

220

230

240

250

260

2013 2014 2015 2016 2017 2018

Number of 510(k) Clearances per CY
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General Observations

Device types Cleared in CY 2018

Dental Abutments (NHA) 66

Endosseous Implants (DZE) 44

Composite Resins (EBF) 18

Aligners (NXC) 11

Snoring/Sleep Devices (LRK) 10

Dental Ceramics (EIH) 10

Resin Bonding Agent (KLE) 9

Dental Handpieces (EFB, EFA, EGS, EKX, EKY) 8

Denture Resin (EBI) 6

Orthodontic Software (PNN) 5

Total cleared in 2018 = 219
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General Observations

Device Type Number of 

Submissions 

Accepted in 

CY 2018

Average FDA 

Review Days

Average 

Submitter Days 

(on hold)

Total Time to 

Decision

Orthodontic Software 2 90.5 96.5 187.0

Dental Handpieces 8 86.9 87.9 174.8

Snoring/Sleep Devices 12 89.2 54.2 143.4

Endosseous Implants 30 82.4 59.6 142.0

Dental Abutments 15 85.0 45.1 130.1
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Refuse-to-Accept (RTA) Challenges

Common challenges include the following elements of the Acceptance 

Checklist for Traditional 510(k)s:

• Device Description 

– Incomplete list and description of each device for which clearance is requested

– Lack of representative engineering drawings or images of the device

– Incomplete list (and 510(k) status) of all components of the device and any accessories to be 

marketed with the device

– Submission does not address recommendations of device-specific guidance nor provides 

alternative approach

• Substantial Equivalence Discussion

– Predicate device is used inconsistently; no justification provided if predicate not used in 

performance testing

– Lack of an discussion why any differences between your device and the predicate do not impact 

safety and effectiveness of your device

• Proposed Labeling

– Instructions for use and/or operator manual does not contain indications, a prescription statement 

(if applicable), and information for professional use, including instructions, hazards, warnings, 

precautions, contraindications, etc.
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RTA Challenges

• Sterilization

– Incomplete information regarding sterilization and reprocessing, including method, validation, sterility assurance level 

(SAL), packaging, end user instructions, cleaning and disinfection methods 

• Biocompatibility 

– Lack of biocompatibility testing or rationale on why such testing is not necessary

– Incomplete material identification of all patient contacting components including all additives; additionally chemical 

identity should be complete

• Performance data

– Test reports not provided 

» Sometimes specifications given, no results are provided

– Irrelevant or inadequate testing that fails to demonstrate how the data supports a finding of substantial equivalence

– Performance data do not address recommendations of device-specific guidance or provide alternative approach
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Substantive Review Challenges and 

Opportunities

• Support performance statements with data

– Any statement of device performance or indication that could impact the evaluation of 

substantial equivalence will be evaluated.

– New performance statements will need to be appropriately supported with data (e.g. nonclinical performance data); some performance statements may necessitate clinical data (e.g. 

statements regarding enhanced clinical outcomes, etc.

• Select appropriate primary predicate device

– Choose a primary predicate device that has the closest intended use (1st) and technological 

characteristics (2nd) to your device. Use the 510(k) Premarket Notification database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

– Reference devices can be used for technological characteristics (assuming no different 

Safety and Effectiveness questions) not found in your primary predicate device. See The 510(k) 

Program guidance (July 28, 2014): www.fda.gov/regulatory-information/search-fda-guidancedocuments/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k
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Substantive Review Challenges and 

Opportunities

• Irrelevant or inadequate performance data to support a finding of substantial equivalence

– Search 510(k) summaries of predicates to determine what tests were relied upon for equivalence

– Use relevant, recognized consensus standards for performance testing: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

– See guidance on appropriate use of standards: https://www.fda.gov/regulatory-information/searchfda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissionsmedical-devices.

– Search the guidance documents for appropriate guidance www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiationemitting-products

• Biocompatibility

– Conduct appropriate testing and/or provide tox risk analysis for why testing is not necessary. See 

2016 guidance: www.fda.gov/regulatory-information/search-fda-guidance-documents/useinternational-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
26

Substantive Review Challenges and 

Opportunities

• End user sterilization/reprocessing

– Provide validated instructions that would allow the user to properly reprocess the device.

– See:

• 2016 sterility guidance www.fda.gov/regulatory-information/search-fda-guidance- documents/submission-and-review-sterility-information-premarket-notification-510k-submissions- devices-labeled

• 2015 reprocessing guidance www.fda.gov/regulatory-information/search-fda-guidance- documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling

• Content of 510(k) summaries should:

– Be complete per 21 CFR 807.92

– Include a comparison of indications and technological characteristics and why any differences do not 

affect substantial equivalence 

– Include a brief description of the tests relied upon for SE determination

– Avoid absolute statement that the device is “safe and effective”; 510(k) process is based on substantial 

equivalence (“as safe and as effective”) to a predicate

– Use the same Indications for Use (IFU) in Summary as that in the IFU statement 

– Not contain trade secret or confidential commercial information, as it will be posted on the FDA’s public 

database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

– Follow good examples of 510(k) Summaries in the database
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Best Practices

• Follow and include a copy of RTA checklist in your submission www.fda.gov/medicaldevices/premarket-notification-510k/acceptance-checklists-510ks

• When responding to RTA (or any deficiency), please indicate or highlight how and 

where the deficiencies have been addressed

• See deficiency guidance: www.fda.gov/regulatory-information/search-fda-guidancedocuments/developing-and-responding-deficiencies-accordance-least-burdensomeprovisions

• Choose an appropriate predicate device 

• Search the 510(k) Premarket Notification database 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

• See The 510(k) Program guidance www.fda.gov/regulatory-information/search-fdaguidance-documents/510k-program-evaluating-substantial-equivalence-premarketnotifications-510k
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Best Practices

• Include summary tables of the tests conducted, even if you include full 

test reports

• https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/recommended-content-and-format-non-clinical-benchperformance-testing-information-premarket

• Clearly explain the differences between your device and the predicate 

device(s) and why the differences do not affect the safety or 

effectiveness of your device

• Please provide text-searchable PDF files

• Proofread final submission

• Ensure consistency throughout submission 

• Please include your direct contact information (email and direct 

phone line); you may also identify alternative contacts, if applicable.
29

• Refer to FDA’s Device Advice website 

www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

• CDRH Learn 

www.fda.gov/training-and-continuing-education/cdrh-learn

• Division of Industry and Consumer Education (DICE) 

www.fda.gov/DICE

• The 510(k) Program and Content guidances

• www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluatingsubstantial-equivalence-premarket-notifications-510k

• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditionaland-abbreviated-510ks

• Consider Pre-Submissions for feedback; See the guidance on the Q-Submission Program, 

www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-andmeetings-medical-device-submissions-q-submission-program

• Contact the review division for additional questions

Premarket Resources
30

• Unsupported indications or performance statements and the selection of 

appropriate predicate devices continue to present the most significant 

challenges for clearance of dental devices

• Using relevant guidance/standards and understanding the differences 

between the subject device and predicate device and clearly articulating and 

demonstrating how these do not affect safety and effectiveness is key to 

overcoming many deficiencies.

Reminders
Postmarket Overview

Srinivas “Nandu” Nandkumar, Ph.D.

Acting Director, Division of Dental Devices 
32

CDRH Vision Statement

“Patients in the U.S. have access to high-quality, safe, and effective 

medical devices of public health importance first in the world. The U.S. 

is the world’s leader in regulatory science, medical device innovation 

and manufacturing, and radiation-emitting product safety. U.S. post- market surveillance quickly identifies poorly performing devices, 

accurately characterizes real-world performance, and facilitates 

device approval or clearance. Devices are legally marketed in the 

U.S. and remain safe, effective, and of high-quality. Consumers, 

patients, their caregivers, and providers have access to 

understandable science-based information about medical devices and 

use this information to make health care decisions.”

www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-mission-vision-and-shared-values
33

Medical Device Reporting (MDR)

• Reports of suspected device-associated 

deaths, serious injuries, and malfunctions 

submitted to FDA

• Mandatory reporting by manufacturers, device 

user facilities, and importers

• Voluntary reporting by health care 

professionals, patients, and consumers

www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

www.fda.gov
34

FDA’s Medical Device Safety Action Plan

(November 2018)

“Ensuring that the FDA is consistently first 

among the world’s regulatory agencies to 

identify and act upon safety signals related to 

medical devices.”

www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-2

www.fda.gov
35

What is a Safety Signal?

• A signal represents information which:

– may arise from one or more sources

– suggests a new potentially causal association, or a new aspect of a known 

association, between a medical device and an event or set of related events

– might justify or require further evaluation and/or action by the Center

• Examples:

– Unanticipated/unlabeled adverse events of clinical significance

– Increase in the severity or rate of a labeled/known event

– New product failure mechanism/mode causing patient injury

– Poor outcomes due to inadequate training, inadequate instructions or human factor 

concerns

– New risks introduced by off-label use

www.fda.gov/regulatory-information/search-fda-guidance-documents/public-notification-emerging-postmarket-medical-device-signals-emerging-signals
36

Signal Detection

• Medical Device Reports (MDR)1

• Post Approval Studies2

• 522 Postmarket Surveillance Studies3

• Device annual reports 

• Consumer complaints

1 www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

2 www.fda.gov/devicepostapproval

3 www.fda.gov/522studies

www.fda.gov
37

Signal Refinement 

• Information Gathering

– Communication with manufacturer as soon as possible

– Literature Search

– Medical Device Report (MDR) Analysis

– Interim results from ongoing postmarket studies

• Assessment of Signal by Signal Team

– Likelihood, magnitude, of event

– Causal relationship

– Potential for mitigation or alternative therapies

www.fda.gov
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Action Plan

Regulatory Actions

Labeling changes

Inspections

Additional Postmarket

Studies (522)

Product Redesign

Market Withdrawal or 

Recall

Public 

Communication

Safety 

Communication1

Letters to Healthcare 

Providers1

www.fda.gov

Webpage

Guidance Documents2

Standards3

1 https://www.fda.gov/medical-devices/medical-device-safety

2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents

3 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
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Market Withdrawals and Recalls

• Market Withdrawal: when a manufacturer makes a business decision to 

withdraw a device from the market for any reason

• Recall: when a manufacturer takes a correction or removal action to 

address a problem with a medical device, in the field, that violates FDA 

regulations.

– Correction vs. removal actions

– Classification of recalls based on risk to health

• Posted in the online Medical Device Recall Database: 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

www.fda.gov
40

Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording 

will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; 

Subheading: Device Specific Topics

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