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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 034 Date of Entry 01/30/2014 
FR Recognition Number 4-137
Standard
ISO  6877 Second edition 2006-04-01
Dentistry - Root-canal obturating points
U.S. Identical Adoption
ANSI ADA Standard No. 78-2013
Dental obturating cones
Scope/Abstract
This International Standard specifies the dimensions and compositional requirements for prefabricated metal or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. It also specifies numerical systems and a colour coding system for designating the s....

Dental root-canal obturating points are marketed sterilized or unsterilized. This International Standard covers the physical attributes expected of such products as supplied. Requirements for sterility are not included, and any claim that the product is sterile is the responsibility of the manufacturer...
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
§872.3820 Resin, Root Canal Filling Class 2 KIF
§872.3840 Point, Silver, Endodontic Class 1 EKL
§872.3850 Gutta-Percha Class 1 EKM
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.
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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