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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4-298
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Standard | |
ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials |
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Identical AdoptionANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials |
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Scope/AbstractThis document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477). |
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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FDA recognition of ISO 4049 Fourth edition 2009-10 [Rec# 4-181] will be superseded by recognition of ISO 4049 Fifth edition 2019-05 [Rec# 4-298]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-181] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-181] 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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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 Contact
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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. |