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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 4-91: ADA / ANSI ADA Specification No.80 2001 (Reaffirmed 2013), dental materials - determination of color stability. (Dental/ENT)

Date of Standard: 2001. 
Addresses of Standards Development Organizations:
 American Dental Association (ADA)
  211 East Chicago Avenue
  Chicago, IL 60611-2678
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Artificial teeth, porcelain teeth, artificial teeth with metal insert, crown and bridge temporary resin, tooth shade resin material, denture relining and repair resin
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3900 Teeth, Artificial, Posterior With Metal Insert Class 1 ELJ
§872.3910 Teeth, Artificial, Backing And Facing Class 1 ELK
§872.3920 Teeth, Porcelain Class 2 ELL
Relevant Guidance:
Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005
FDA Technical Contact:
 Michael Adjodha
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2606
  Silver Spring MD 20993
  301/796-6276
  email: michael.adjodha@fda.hhs.gov
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