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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 4-135: ISO 10139-1 Second edition 2005-02-15, dentistry - soft lining materials for removable dentures - part 1: materials for short-term use. (Dental/ENT)

Date of Standard: 2005. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
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, IDE, HDE, PDP, Quality System Regulation
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard. 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
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
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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