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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Recognition 04/04/2016 
FR Recognition Number 4-194
Standard
ANSI ADA Specification No. 78:2006
Dental obturating cones (Modified adoption of ISO 6877-1:1995, Dental obturating points)
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
§872.3850 Gutta-Percha Class 1 EKM
§872.3840 Point, Silver, Endodontic Class 1 EKL
§872.3820 Resin, Root Canal Filling Class 2 KIF
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Michael Adjodha
  FDA/OMPT/CDRH/ODE/DAGID/DEDB
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
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