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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 4-284
Standard
ISO 10873 Second edition 2021-07
Dentistry - Denture adhesives
Scope/Abstract
This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products.

This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.
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
§872.3400 Adhesive, Denture, Acacia And Karaya With Sodium Borate Class 1 KOM
§872.3400 Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight Class 3 MMU
§872.3400 Adhesive, Denture, Karaya With Sodium Borate Class 3 KOR
§872.3410 Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer Class 1 KOL
§872.3410 Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) Class 1 KOQ
§872.3410 Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer Class 1 KXW
§872.3420 Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer Class 3 KOS
§872.3450 Adhesive, Denture, Karaya Class 1 KOP
§872.3450 Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer Class 1 KXX
§872.3480 Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) Class 3 KON
§872.3490 Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Class 1 KOO
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@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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