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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 4-130: ADA ADA Specification No.17:1983 (Reaffirmed 2006), denture base temporary relining resins. (Dental/ENT)

Date of Standard: 1983. 
Address of Standards Development Organization:
 American Dental Association (ADA)
  211 East Chicago Avenue
  Chicago, IL 60611-2678
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
OTC denture reliner
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3560 Reliner, Denture, Over The Counter Class 2 EBP
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
Relevant Guidance:
Guidance for Industry and FDA Staff OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits Document issued on: August 18, 1998
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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