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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Dental

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
872.1720 PULP TESTER II  
  EAT -  Tester, Pulp   Pilot  
872.1740 CARIES DETECTION DEVICE II  
  LFC -  Device, Caries Detection   Pilot  
872.1800 EXTRAORAL SOURCE X-RAY SYSTEM II  
 
  EHD -  Unit, X-Ray, Extraoral With Timer      
  MUH -  System,X-Ray,Extraoral Source,Digital      
872.1810 INTRAORAL SOURCE X-RAY SYSTEM II  
 
  EAP -  Unit, X-Ray, Intraoral      
872.1830 CEPHALOMETER II  
  EAG -  Cephalometer   Pilot  
872.1870 IN VIVO SULFIDE DETECTION DEVICE II  
 
  MVH -  Device, Detection, Sulfide      
872.3060 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE II  
 
  EJS -  Alloy, Other Noble Metal      
  EJT -  Alloy, Gold-Based Noble Metal      
872.3200 RESIN TOOTH BONDING AGENT II  
 
  KLE -  Agent, Tooth Bonding, Resin      
872.3250 CALCIUM HYDROXIDE CAVITY LINER II  
  EJK -  Liner, Cavity, Calcium Hydroxide   Pilot  
872.3260 CAVITY VARNISH II  
  LBH -  Varnish, Cavity   Pilot  
872.3275 DENTAL CEMENT II  
  EMA -  Cement, Dental      
  MZW -  Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief      
872.3300 HYDROPHILIC RESIN COATING FOR DENTURES II  
  EBE -  Coating, Denture Hydrophilic, Resin   Pilot  
872.3310 COATING MATERIAL FOR RESIN FILLINGS II  
  EBD -  Coating, Filling Material, Resin   Pilot  
872.3520 DENTURE CLEANSER I  
  NUX -  Cleanser, Denture, Prescription   Pilot  
872.3540 OTC DENTURE PAD AND DENTURE CUSHION II  
  EHR -  Pad, Denture, Over The Counter   Pilot  
  EHS -  Cushion, Denture, Over The Counter   Pilot  
872.3560 OTC DENTURE RELINER II  
  EBP -  Reliner, Denture, Over The Counter   Pilot  
872.3570 OTC DENTURE REPAIR KIT II  
  EBO -  Over The Counter Denture Repair Kit   Pilot  
872.3590 PREFORMED PLASTIC DENTURE TOOTH II  
  ELM -  Denture, Plastic, Teeth   Pilot  
872.3600 PARTIALLY FABRICATED DENTURE KIT II  
  EKO -  Denture Preformed (Partially Prefabricated Denture)   Pilot  
872.3660 IMPRESSION MATERIAL II  
PDF Guidance file for IMPRESSION MATERIAL (21CFR872.3660)  
  ELW -  Material, Impression      
872.3690 TOOTH SHADE RESIN MATERIAL II  
  EBF -  Material, Tooth Shade, Resin      
872.3710 BASE METAL ALLOY II  
  EJH -  Alloy, Metal, Base      
872.3750 BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER II  
  DYH -  Adhesive, Bracket And Tooth Conditioner, Resin   Pilot  
  KZP -  Solution, Cement Disolving   Pilot  
872.3760 DENTURE RELINING REPAIRING OR REBASING RESIN II  
  EBI -  Resin, Denture, Relining, Repairing, Rebasing   Pilot  
872.3765 PIT AND FISSURE SEALANT AND CONDITIONER II  
  EBC -  Sealant, Pit And Fissure, And Conditioner   Pilot  
872.3770 TEMPORARY CROWN AND BRIDGE RESIN II  
  EBG -  Crown And Bridge, Temporary, Resin   Pilot  
872.3820 ROOT CANAL FILLING RESIN II  
  KIF -  Resin, Root Canal Filling   Pilot  
872.3890 ENDODONTIC STABILIZER SPLINT II  
  ELS -  Splint, Endodontic Stabilizing   Pilot  
872.3920 PORCELAIN TOOTH II  
  ELL -  Teeth, Porcelain   Pilot  
872.4120 BONE CUTTING INSTRUMENTS AND ACCESSORIES II  
  DZH -  Saw, Bone, Ac-Powered   Pilot  
  DZI -  Drill, Bone, Powered   Pilot  
  DZJ -  Driver, Wire, And Bone Drill, Manual   Pilot  
  KMW -  Handpiece, Rotary Bone Cutting   Pilot  
  MXF -  System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation   Pilot  
872.4200 DENTAL HANDPIECES AND ACCESSORIES I  
  EBW -  Controller, Foot, Handpiece And Cord      
  EFA -  Handpiece, Belt And/Or Gear Driven, Dental      
  EFB -  Handpiece, Air-Powered, Dental      
  EGS -  Handpiece, Contra- And Right-Angle Attachment, Dental      
  EKX -  Handpiece, Direct Drive, Ac-Powered      
  EKY -  Handpiece, Water-Powered      
872.4465 GAS POWERED JET INJECTOR II  
  EGQ -  Injector, Jet, Gas-Powered   Pilot  
872.4475 SPRING-POWERED JET INJECTOR II  
  EGM -  Injector, Jet, Mechanical-Powered   Pilot  
872.4565 DENTAL HAND INSTRUMENT I  
  EGI -  Parallelometer   Pilot  
  EIB -  Syringe, Irrigating (Dental)   Pilot  
872.4840 ROTARY SCALER II  
  ELB -  Scaler, Rotary   Pilot  
872.4850 ULTRASONIC SCALER II  
  ELC -  Scaler, Ultrasonic   Pilot  
872.4920 ELECTROSURGICAL UNIT AND ACCESSORIES II  
  EKZ -  Unit, Electrosurgical, And Accessories, Dental   Pilot  
872.5470 ORTHODONTIC PLASTIC BRACKET II  
  DYW -  Bracket, Plastic, Orthodontic   Pilot  
  NJM -  Bracket, Ceramic, Orthodontic   Pilot  
  NXC -  Aligner, Sequential   Pilot  
872.5500 EXTRAORAL ORTHODONTIC HEADGEAR II  
  DZB -  Headgear, Extraoral, Orthodontic   Pilot  
872.5550 FLUID FILLED TEETHING RING II  
  KKO -  Ring, Teething, Fluid-Filled   Pilot  
872.5570 INTRAORAL DEVICES FOR SNORING AND INTRAORAL DEVICES FOR SNORING AND OBSTRUCTIVE SLEEP APNEA II  
  LQZ -  Device, Jaw Repositioning   Pilot  
  LRK -  Device, Anti-Snoring      
872.6070 ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION II  
  EBZ -  Activator, Ultraviolet, For Polymerization   Pilot  
872.6080 AIRBRUSH II  
  KOJ -  Airbrush   Pilot  
872.6250 CHAIR WITH A UNIT I  
 General Guidance
  KLC -  Chair, Dental, With Operative Unit      
872.6350 ULTRAVIOLET DETECTOR II  
  EAQ -  Detector, Ultraviolet   Pilot  
872.6640 DENTAL OPERATIVE UNIT I  
 General Guidance
  DYN -  Mouthpiece, Saliva Ejector      
  EBR -  Unit, Suction Operatory      
  EHZ -  Evacuator, Oral Cavity      
  EIA -  Unit, Operative Dental      
872.6660 PORCELAIN POWDER FOR CLINICAL USE II  
  EIH -  Powder, Porcelain   Pilot  
872.6710 BOILING WATER STERILIZER I  
 General Guidance
  ECG -  Sterilizer, Boiling Water      
872.6770 CARTRIDGE SYRINGE II  
  EJI -  Syringe, Cartridge   Pilot  

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