| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
061
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Date of Entry 12/18/2023
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|
FR Recognition Number
|
4-321
|
| Standard | |
ISO 23450 First edition 2021-03
Dentistry - Intraoral camera |
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Scope/AbstractThis 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
|
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. |
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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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
