Recognized Consensus Standards

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.

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FDA recognition of ISO 10873 First edition 2010-09 [Rec# 4-282] will be superseded by recognition of ISO 10873 Second edition 2021-07 [Rec# 4-284].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