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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 061 Date of Entry 12/18/2023 
FR Recognition Number 4-321
ISO  23450 First edition 2021-03
Dentistry - Intraoral camera
This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking.

This document is not applicable to:
a) powered polymerization activators for polymerization of dental materials;
b) exclusively extraoral camera equipment to prepare overviews or to record treatments;
c) dental microscopes for minimally invasive treatments;
d) medical endoscopes;
e) camera handpieces for tooth illumination (transillumination);
f) CAD or CAM scanner handpieces;
g) combinations of dental instruments with camera functions;
h) cameras for endodontic purposes;
i) devices for root canal inspection (endoscopic microcameras);
j) cameras for tool navigation;
k) cameras for determination of tooth colour.
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
§872.3661 Intraoral Camera Class 2 QJK
Relevant FDA Guidance and/or Supportive Publications*
Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations - Class II Special Controls Guidance Document for Industry and FDA, issued April 2003.

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
 Bobak Shirmohammadi
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.