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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 Entry 08/14/2015 
FR Recognition Number 4-105
ANSI ADA Standard No. 75 (Reaffirmed 2014) Resilient Lining Materials for Removable Dentures, Part 1: Short-Term Materials
Scope/Abstract
This part of ANSI/ADA Standard No. 75 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for denture lining materials suitable for short-term use.
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
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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