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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 4-130
Standard
ANSI ADA  Standard No. 17-1983 (R2014)
Denture Base Temporary Relining Resins
Scope/Abstract
This standard is for pink and clear powder/liquid auto-polymerizing (self-initiating cure) type hard-setting resins used as temporary relining materials for denture bases. Soft relining materials are not covered by this standard.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
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 FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits Document issued on: August 18, 1998

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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