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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 066 Date of Entry 05/25/2026 
FR Recognition Number 4-369
Standard
ANSI ADA  Standard No. 113-2015
Periodontal Curettes, Dental Scalers and Excavators
Scope/Abstract
This standard specifies the general material, performance, and dimensional requirements for periodontal curettes, dental scalers and excavators.

This standard is a modified adoption of ISO 13397-1:1995, Periodontal curettes, dental scalers and excavators - Part 1: General requirements; ISO 13397-2:2005, Dentistry - Periodontal curettes, dental scalers and excavators - part 2: Periodontal curettes of Gr-type; and ISO 13397-2/Amendement 1:2012, Color coding.
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 Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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