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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 064 Date of Entry 05/26/2025 
FR Recognition Number 4-346
Standard
ISO  9680 Fourth edition 2021-11
Dentistry - Operating lights
Identical Adoption
ANSI ADA Standard No. 89-2023
Dentistry - Dental Operating Lights
Scope/Abstract
This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.

This document applies to operating lights, irrespective of the technology of the light source.

This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
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
§872.4630 Light, Operating, Dental Class 1 EAZ
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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  Michael.Adjodha@fda.hhs.gov
 Ran Huo
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  240-402-6705
  Ran.Huo@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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