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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 4-117: ADA / ANSI Specification No. 12: 2002 (Reaffirmed 2008), denture base polymers. (Dental/ENT)

Date of Standard: 2008. 
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:
Denture Base Polymers
Processes Affected:
510(K), PMA, IDE, HDE, PDP, Quality System Regulation
Extent of Recognition:
Complete standard and any annexes. Data from the test methods in the standard is needed. Additional testing may be necessary for some products.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
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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