Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

063

Date of Entry 12/23/2024

FR Recognition Number

4-328

Standard

ANSI ADA Standard No. 57-2021
Endodontic Sealing Materials

Scope/Abstract

This standard specifies requirements and test methods for endodontic sealing materials, which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It covers materials intended for orthograde use i.e. a root filling placed from the coronal aspect of a tooth.

Modified adoption of ISO 6876:2012, Dentistry - Root canal sealing 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.

Transition Period

FDA recognition of ANSI ADA Standard No. 57-2000 (R2012) [Rec# 4-97] will be superseded by recognition of ANSI ADA Standard No. 57-2021 [Rec# 4-328]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-97] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 4-97] 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

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

Michael Adjodha

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6276

Michael.Adjodha@fda.hhs.gov

Diana Cartagena Diaz

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-0435

Diana.Diazcartagena@fda.hhs.gov

Standards Development Organizations