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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 November 22, 2021

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. II  
  LFC -  Device, Caries Detection  
872.1745 Laser fluorescence caries detection device. II  
  NTK -  Caries Detector, Laser Light, Transmission  
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  
872.1870 Sulfide detection device. II  
  MVH -  Device, Detection, Sulfide  
872.3070 Dental amalgam, mercury, and amalgam alloy. II  
  EJJ -  Alloy, Amalgam  
  ELY -  Mercury  
  OIV -  Dental Amalgam  
872.3200 Resin tooth bonding agent. II  
  KLE -  Agent, Tooth Bonding, Resin  
872.3240 Dental bur. I  
  NME -  Bur, Diamond Coated, Reprocessed  
872.3250 Calcium hydroxide cavity liner. II  
  EJK -  Liner, Cavity, Calcium Hydroxide  
872.3260 Cavity varnish. II  
  LBH -  Varnish, Cavity  
  PHR -  Diammine Silver Fluoride Dental Hypersensitivity Varnish  
872.3275 Dental cement. II  
  EMA -  Cement, Dental  
  MZW -  Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief  
872.3310 Coating material for resin fillings. II  
  EBD -  Coating, Filling Material, Resin  
872.3660 Impression material. II  
  ELW -  Material, Impression  
872.3690 Tooth shade resin material. II  
  EBF -  Material, Tooth Shade, Resin  
872.3750 Bracket adhesive resin and tooth conditioner. II  
  DYH -  Adhesive, Bracket And Tooth Conditioner, Resin  
  KZP -  Solution, Cement Dissolving  
872.3760 Denture relining, repairing, or rebasing resin. II  
  EBI -  Resin, Denture, Relining, Repairing, Rebasing  
872.3765 Pit and fissure sealant and conditioner. II  
  EBC -  Sealant, Pit And Fissure, And Conditioner  
872.3770 Temporary crown and bridge resin. II  
  EBG -  Crown And Bridge, Temporary, Resin  
  POW -  Crown And Bridge, Long-Term Temporary, Resin  
872.3820 Root canal filling resin. II  
  KIF -  Resin, Root Canal Filling  
872.3920 Porcelain tooth. II  
  ELL -  Teeth, Porcelain  
872.4120 Bone cutting instrument and accessories. II  
  DZH -  Saw, Bone, Ac-Powered  
  DZI -  Drill, Bone, Powered  
  DZJ -  Driver, Wire, And Bone Drill, Manual  
  KMW -  Handpiece, Rotary Bone Cutting  
  MXF -  System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation  
872.4200 Dental handpiece 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  
  NYL -  Handpiece, Air-Powered, Root Canal Irrigation  
872.4465 Gas-powered jet injector. II  
  EGQ -  Injector, Jet, Gas-Powered  
872.4475 Spring-powered jet injector. II  
  EGM -  Injector, Jet, Mechanical-Powered  
872.4535 Dental diamond instrument. I  
  NLD -  Instrument, Diamond, Dental, Reprocessed  
872.4730 Dental injecting needle. I  
  NMW -  Needle, Dental, Reprocessed  
872.4840 Rotary scaler. II  
  ELB -  Scaler, Rotary  
872.4850 Ultrasonic scaler. II  
  ELC -  Scaler, Ultrasonic  
872.4920 Dental electrosurgical unit and accessories. II  
  EKZ -  Unit, Electrosurgical, And Accessories, Dental  
872.5410 Orthodontic appliance and accessories. I  
  NQS -  Bracket, Metal, Orthodontic, Reprocessed  
872.5470 Orthodontic plastic bracket. II  
  DYW -  Bracket, Plastic, Orthodontic  
  NJM -  Bracket, Ceramic, Orthodontic  
  NLC -  Bracket, Plastic, Orthodontic, Reprocessed  
  NXC -  Aligner, Sequential  
  OYH -  Orthodontic Vibratory Accessory  
  PLH -  Orthodontic Led Accessory  
  PNN -  Orthodontic Software  
872.5500 Extraoral orthodontic headgear. II  
  DZB -  Headgear, Extraoral, Orthodontic  
872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II  
  OZR -  Intraoral Pressure Gradient Device  
  LQZ -  Device, Jaw Repositioning  
  LRK -  Device, Anti-Snoring  
  OHP -  Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea  
  PLC -  Sleep Appliances With Patient Monitoring  
  MYB -  Pillow, Cervical (For Mild Sleep Apnea)  
872.5580 Oral rinse to reduce the adhesion of dental plaque. II  
  NTO -  Rinse, Oral, Antibacterial (By Physical Means)  
872.6070 Ultraviolet activator for polymerization. II  
  EBZ -  Activator, Ultraviolet, For Polymerization  
872.6080 Airbrush. II  
  KOJ -  Airbrush  
  PIP -  Prophy Powder, Airbrush Accessory  
872.6250 Dental chair and accessories. I  
  KLC -  Chair, Dental, With Operative Unit  
872.6350 Ultraviolet detector. II  
  EAQ -  Detector, Ultraviolet  
  NXV -  Diagnostic Light, Soft Tissue Detector  
872.6640 Dental operative unit and accessories. I  
  EIA -  Unit, Operative Dental  
872.6660 Porcelain powder for clinical use. II  
  EIH -  Powder, Porcelain  
872.6710 Boiling water sterilizer. I  
  ECG -  Sterilizer, Boiling Water  

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