Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

066

Date of Entry 05/25/2026

FR Recognition Number

4-377

Standard

ISO 9173-1 Third edition 2016-10
Dentistry - Extraction forceps - Part 1: General requirements

Scope/Abstract

ISO 9173-1:2016 specifies the general performance requirements for extraction forceps used in dentistry.

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	Instruments, Dental Hand	Class 1	DZN
§872.4565	Handle, Instrument, Dental	Class 1	EJB
§872.4565	Pliers, Operative	Class 1	EJY
§872.4565	Forceps, Tooth Extractor, Surgical	Class 1	EMG
§872.4565	Forceps, Rongeur, Surgical	Class 1	EMH

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