Recognized standard
9680 Fourth edition 2021-11 Standard No. 89-2023
FDA recognition 4-346 · ISO · Dental/ENT
Key facts
| Recognition number | 4-346 |
|---|---|
| Designation | 9680 Fourth edition 2021-11 Standard No. 89-2023 |
| Title | Dentistry - Operating lights Dentistry - Dental Operating Lights |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | 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… |
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: