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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 4-242
ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
Scope/Abstract
This document specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.
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.
Transition Period
FDA recognition of ISO 10139-1 Second edition 2005-02-15 including Tech. Corr. 2006 [Rec# 4-214] will be superseded by recognition of ISO 10139-1 Third edition 2018-03 [Rec# 4-242]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-214] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 4-214] will not be accepted.
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
Relevant FDA Guidance and/or Supportive Publications*
OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA Staff, Issued August 1998.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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