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

4-396

Standard

ISO 22570 First edition 2020-02
Dentistry - Spoons and bone curettes

Scope/Abstract

This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures.

It specifies shapes and dimensions as well as information for marking.

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	Curette, Operative	Class 1	EKE
§872.4565	Curette, Endodontic	Class 1	EKT
§872.4565	Curette, Surgical, Dental	Class 1	EMK
§872.4565	Curette, Periodontic	Class 1	EMS

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