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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 June 17, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Dental

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
872.1740 Caries detection device.    
  LFC -  Device, Caries Detection II
872.1745 Laser fluorescence caries detection device.    
  NTK -  Caries Detector, Laser Light, Transmission II
872.1800 Extraoral source x-ray system.    
  EHD -  Unit, X-Ray, Extraoral With Timer II
  MUH -  System, X-Ray, Extraoral Source, Digital II
872.1810 Intraoral source x-ray system.    
  EAP -  Unit, X-Ray, Intraoral II
872.1830 Cephalometer.    
  EAG -  Cephalometer II
872.1870 Sulfide detection device.    
  MVH -  Device, Detection, Sulfide II
872.3070 Dental amalgam, mercury, and amalgam alloy.    
  EJJ -  Alloy, Amalgam II
  ELY -  Mercury II
  OIV -  Dental Amalgam II
872.3200 Resin tooth bonding agent.    
  KLE -  Agent, Tooth Bonding, Resin II
872.3240 Dental bur.    
  NME -  Bur, Diamond Coated, Reprocessed I
872.3250 Calcium hydroxide cavity liner.    
  EJK -  Liner, Cavity, Calcium Hydroxide II
872.3260 Cavity varnish.    
  LBH -  Varnish, Cavity II
  PHR -  Diammine Silver Fluoride Dental Hypersensitivity Varnish II
872.3275 Dental cement.    
  EMA -  Cement, Dental II
  MZW -  Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief II
872.3310 Coating material for resin fillings.    
  EBD -  Coating, Filling Material, Resin II
872.3660 Impression material.    
  ELW -  Material, Impression II
872.3690 Tooth shade resin material.    
  EBF -  Material, Tooth Shade, Resin II
872.3750 Bracket adhesive resin and tooth conditioner.    
  DYH -  Adhesive, Bracket And Tooth Conditioner, Resin II
  KZP -  Solution, Cement Dissolving II
872.3760 Denture relining, repairing, or rebasing resin.    
  EBI -  Resin, Denture, Relining, Repairing, Rebasing II
872.3765 Pit and fissure sealant and conditioner.    
  EBC -  Sealant, Pit And Fissure, And Conditioner II
872.3770 Temporary crown and bridge resin.    
  EBG -  Crown And Bridge, Temporary, Resin II
  POW -  Crown And Bridge, Long-Term Temporary, Resin II
872.3820 Root canal filling resin.    
  KIF -  Resin, Root Canal Filling II
872.3920 Porcelain tooth.    
  ELL -  Teeth, Porcelain II
872.4120 Bone cutting instrument and accessories.    
  DZH -  Saw, Bone, Ac-Powered II
  DZI -  Drill, Bone, Powered II
  DZJ -  Driver, Wire, And Bone Drill, Manual II
  KMW -  Handpiece, Rotary Bone Cutting II
  MXF -  System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation II
872.4200 Dental handpiece and accessories.    
  EBW -  Controller, Foot, Handpiece And Cord I
  EFA -  Handpiece, Belt And/Or Gear Driven, Dental I
  EFB -  Handpiece, Air-Powered, Dental I
  EGS -  Handpiece, Contra- And Right-Angle Attachment, Dental I
  EKX -  Handpiece, Direct Drive, Ac-Powered I
  EKY -  Handpiece, Water-Powered I
  NYL -  Handpiece, Air-Powered, Root Canal Irrigation I
872.4465 Gas-powered jet injector.    
  EGQ -  Injector, Jet, Gas-Powered II
872.4475 Spring-powered jet injector.    
  EGM -  Injector, Jet, Mechanical-Powered II
872.4535 Dental diamond instrument.    
  NLD -  Instrument, Diamond, Dental, Reprocessed I
872.4730 Dental injecting needle.    
  NMW -  Needle, Dental, Reprocessed I
872.4840 Rotary scaler.    
  ELB -  Scaler, Rotary II
872.4850 Ultrasonic scaler.    
  ELC -  Scaler, Ultrasonic II
872.4920 Dental electrosurgical unit and accessories.    
  EKZ -  Unit, Electrosurgical, And Accessories, Dental II
872.5410 Orthodontic appliance and accessories.    
  NQS -  Bracket, Metal, Orthodontic, Reprocessed I
872.5470 Orthodontic plastic bracket.    
  DYW -  Bracket, Plastic, Orthodontic II
  NJM -  Bracket, Ceramic, Orthodontic II
  NLC -  Bracket, Plastic, Orthodontic, Reprocessed II
  NXC -  Aligner, Sequential II
  OYH -  Orthodontic Vibratory Accessory II
  PLH -  Orthodontic Led Accessory II
  PNN -  Orthodontic Software II
872.5500 Extraoral orthodontic headgear.    
  DZB -  Headgear, Extraoral, Orthodontic II
872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.    
  OZR -  Intraoral Pressure Gradient Device II
  LQZ -  Device, Jaw Repositioning II
  LRK -  Device, Anti-Snoring II
  OHP -  Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea II
  PLC -  Sleep Appliances With Patient Monitoring II
  MYB -  Pillow, Cervical (For Mild Sleep Apnea) II
872.5580 Oral rinse to reduce the adhesion of dental plaque.    
  NTO -  Rinse, Oral, Antibacterial (By Physical Means) II
872.6070 Ultraviolet activator for polymerization.    
  EBZ -  Activator, Ultraviolet, For Polymerization II
872.6080 Airbrush.    
  KOJ -  Airbrush II
  PIP -  Prophy Powder, Airbrush Accessory II
872.6250 Dental chair and accessories.    
  KLC -  Chair, Dental, With Operative Unit I
872.6350 Ultraviolet detector.    
  EAQ -  Detector, Ultraviolet II
  NXV -  Diagnostic Light, Soft Tissue Detector II
872.6640 Dental operative unit and accessories.    
  EIA -  Unit, Operative Dental I
872.6660 Porcelain powder for clinical use.    
  EIH -  Powder, Porcelain II
872.6710 Boiling water sterilizer.    
  ECG -  Sterilizer, Boiling Water I

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