Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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043
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Date of Entry 06/27/2016
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FR Recognition Number
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4-202
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Standard | |
ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom) |
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Scope/AbstractThis standard is for endodontic Hedstrom files for hand use only having a working part taper of 2% (0.02 millimeter per millimeter of length) as used in endodontic preparation or shaping operations. |
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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 |
§872.4565 |
File, Pulp Canal, Endodontic
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Class 1
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EKS
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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 Contact
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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. |