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

4-375

Standard

ANSI ADA Standard No. 197-2021
Spoons and Bone Curettes in Dentistry

Scope/Abstract

This specification is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

This standard is a modified adoption of ISO 22570:2020 Dentistry - Spoons and bone curettes.

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 Organizations