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

4-385

Standard

ISO 13397-2 Second edition 2005-06 [Including AMD1:2012]
Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)]

Scope/Abstract

ISO 13397-2:2005 specifies the designs and dimensions for Gr-type periodontal 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	Excavator, Dental, Operative	Class 1	EKC
§872.4565	Curette, Operative	Class 1	EKE
§872.4565	Curette, Endodontic	Class 1	EKT
§872.4565	Curette, Surgical, Dental	Class 1	EMK
§872.4565	Scaler, Periodontic	Class 1	EMN
§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