Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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4-282
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Standard | |
ISO 10873 First edition 2010-09 Dentistry - Denture adhesives |
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U.S. Identical AdoptionANSI ADA Standard No. 135-2015 Denture Adhesives |
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Scope/AbstractISO 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. |
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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FDA recognition of ISO 10873 First edition 2010-09 [Rec# 4-282] will be superseded by recognition of ISO 10873 Second edition 2021-07 [Rec# 4-284].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. |