Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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.
Transition Period
FDA recognition of ISO 10873 First edition 2010-09 [Rec# 4-282] will be superseded by recognition of ISO 10873 Second edition 2021-07 [Rec# 4-284]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-282] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 4-282] will not be accepted.
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
 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.
-
-