Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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4-97
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Standard | |
ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material |
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Scope/AbstractThis standard is for materials used in endodontics within the tooth to seal the root canal space. |
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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 |
§872.3820 |
Resin, Root Canal Filling
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Class 2
|
KIF
|
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Relevant FDA Guidance and/or Supportive Publications*
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. |