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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 4-130
ANSI ADA Standard No. 17 (Reaffirmed 2014)
Denture Base Temporary Relining Resins
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
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.3560 Reliner, Denture, Over The Counter Class 2 EBP
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
FDA Technical Contact
 Michael Adjodha
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)