Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 4-309
Standard
ISO  6877 Third edition 2021-09
Dentistry - Endodontic obturating materials
Identical Adoption
ANSI ADA Standard No. 78-2021
Dentistry - Endodontic Obturating Materials
Scope/Abstract
This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points.

Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied.

Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use.

This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

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.
Transition Period
FDA recognition of ISO 6877 Second edition 2006-04 [Rec# 4-137] will be superseded by recognition of ISO 6877 Third edition 2021-09 [Rec# 4-309]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-137] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-137] will not be accepted.
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 Contacts
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@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.
-
-