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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 4-282
Standard
ISO 10873 First edition 2010-09
Dentistry - Denture adhesives
U.S. Identical Adoption
ANSI ADA Standard No. 135-2015
Denture Adhesives
Scope/Abstract
ISO 10873:2010 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.

ISO 10873:2010 is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by dental professionals.

ISO 10873:2010 does not specify qualitative or quantitative requirements for freedom from biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.
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
FDA Technical Contacts
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@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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