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U.S. Department of Health and Human Services

List of Devices for Third Party Review under the FDA Modernization Act of 1997

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The US/EU Mutual Recognition Agreement: The Medical Device Annex (picture of the united states, a medical device, and europe)

(See Related Information)List of Devices for MRA Review

This page identifies the list of devices eligible for 510(k) review or type examination under the Mutual Recognition Agreement (MRA).  The list contains the classification names of the medical devices, corresponding section numbers in the 21 Code of Federal Regulations (CFR), three letter product classification codes, and the device class. Most importantly, the far right column references guidance or standards appropriate to the particular medical device, whether specific guidance for the device exists, or general guidance in the absence of specific guidance. The text in this column is a hyperlinked; when viewed in a browser with an Internet connection, double clicking on the text will open up the applicable page(s) of guidance on the FDA site.


Please note that a modification of this list is currently under consideration by the European Commission.



Dental

Help More About Classification
Section No. Regulation Name
Product Code-Device Name
Class
Relevant
Guidance/Standard
872.3060 Noble metal alloy.  
 
  EJS -  Alloy, Other Noble Metal II  
  EJT -  Alloy, Gold-Based Noble Metal II  
872.3200 Resin tooth bonding agent.  
 
  KLE -  Agent, Tooth Bonding, Resin II  
872.3275 Dental cement.  
  HTML Guidance file for Dental cement. (21CFR872.3275)
PDF Guidance file for Dental cement. (21CFR872.3275)  
  EMA -  Cement, Dental II  
872.3660 Impression material.  
  HTML Guidance file for Impression material. (21CFR872.3660)
PDF Guidance file for Impression material. (21CFR872.3660)  
  ELW -  Material, Impression II  
872.3690 Tooth shade resin material.  
  HTML Guidance file for Tooth shade resin material. (21CFR872.3690)
PDF Guidance file for Tooth shade resin material. (21CFR872.3690)  
  EBF -  Material, Tooth Shade, Resin II  
872.3710 Base metal alloy.  
  HTML Guidance file for Base metal alloy. (21CFR872.3710)
PDF Guidance file for Base metal alloy. (21CFR872.3710)  
  EJH -  Alloy, Metal, Base II  
872.4200 Dental handpiece and accessories.  
  HTML Guidance file for Dental handpiece and accessories. (21CFR872.4200)
PDF Guidance file for Dental handpiece and accessories. (21CFR872.4200)  
  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  
872.6250 Dental chair and accessories.  
 General Guidance
  KLC -  Chair, Dental, With Operative Unit I  
872.6640 Dental operative unit and accessories.  
 General Guidance
  DYN -  Mouthpiece, Saliva Ejector I  
  EBR -  Unit, Suction Operatory I  
  EHZ -  Evacuator, Oral Cavity I  
  EIA -  Unit, Operative Dental I  
872.6710 Boiling water sterilizer.  
 General Guidance
  ECG -  Sterilizer, Boiling Water I  

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