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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 4-149
Standard
ANSI ADA  Standard No. 39-2006 (R2011)
Pit and Fissure Sealants
Scope/Abstract
This standard specifies requirements and test methods for resin-based materials suitable for sealing pits and fissures in teeth. This standard covers both chemically cured and external-energy-activated materials.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3765 Sealant, Pit And Fissure, And Conditioner Class 2 EBC
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notifiation [510(k)] Submissions Document issued on: 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.
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  Michael.Adjodha@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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