| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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4-253
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| Standard | |
ANSI ADA Standard No. 27-2016
Polymer-based Restorative Materials |
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Scope/Abstract| This Standard 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 cavities in the teeth and for luting. The polymer-based luting materials covered by this Standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and fixed partial prostheses. This Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material. This Standard does not cover materials intended to prevent caries (see ISO 6874) 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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3690 |
Material, Tooth Shade, Resin |
Class 2 |
EBF |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions, Issued October 26, 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 Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
