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

4-333

Standard

ISO  3630-4 Second edition 2023-08
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments

Scope/Abstract

This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling

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
§872.4565	Broach, Endodontic	Class 1	EKW

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.