Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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4-222
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Standard | |
ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants |
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Identical AdoptionANSI ADA Standard No. 39-2020 Pit and Fissure Sealants |
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Scope/AbstractThis International Standard specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth.
This International Standard covers both self-curing and external-energy-activated materials. |
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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 |
§872.3765 |
Sealant, Pit And Fissure, And Conditioner
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Class 2
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EBC
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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 Document issued on: October 26, 2005
http://www.fda.gov/RegulatoryInformation/Guidances/ucm071576.htm
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. |