Recognized standard
9873 Fourth edition 2019-03 Standard No. 191-2020
FDA recognition 4-296 · ISO · Dental/ENT
Key facts
| Recognition number | 4-296 |
|---|---|
| Designation | 9873 Fourth edition 2019-03 Standard No. 191-2020 |
| Title | Dentistry - Intra-oral mirrors Intra-Oral Mirrors |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requirements for metallic casing and metallic handles are given. |
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: