Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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4-284
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Standard | |
ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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FDA recognition of ISO 10873 First edition 2010-09 [Rec# 4-282] will be superseded by recognition of ISO 10873 Second edition 2021-07 [Rec# 4-284].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. |
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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 |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |