Recognized standard
23450 First edition 2021-03
FDA recognition 4-321 · ISO · Dental/ENT
Key facts
| Recognition number | 4-321 |
|---|---|
| Designation | 23450 First edition 2021-03 |
| Title | Dentistry - Intraoral camera |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: