K946073 is an FDA 510(k) clearance for the ORALVUE DENTAL MIRROR. This device is classified as a Mirror, Mouth (Class I - General Controls, product code EAX).
Submitted by Hines Group , Ltd. (Nyw York, US). The FDA issued a Cleared decision on February 16, 1995, 71 days after receiving the submission on December 7, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K946073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1994 |
| Decision Date | February 16, 1995 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EAX — Mirror, Mouth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |