Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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4-302
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Standard | |
ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials |
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Identical AdoptionANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials |
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Scope/AbstractThis document specifies requirements and test methods for polymer-based crown and veneering materials used in dentistry. This document applies to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires. |
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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FDA recognition of ISO 10477 Third edition 2018-06 [Rec# 4-248] will be superseded by recognition of ISO 10477 Fourth edition 2020-10 [Rec# 4-302]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-248] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-248] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3690 |
Material, Tooth Shade, Resin
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Class 2
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EBF
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§872.3770 |
Crown And Bridge, Temporary, Resin
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Class 2
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EBG
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, issued October 2005.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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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. |