K923949 is an FDA 510(k) clearance for the SYLVAN DENTAL HEADLIGHT SYSTEM. This device is classified as a Light, Surgical Headlight (Class I - General Controls, product code EBA).
Submitted by Sylvan Medical Fiberoptics (North Huntingdon, US). The FDA issued a Cleared decision on October 16, 1992, 72 days after receiving the submission on August 5, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.
| 510(k) Number | K923949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1992 |
| Decision Date | October 16, 1992 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBA — Light, Surgical Headlight |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4630 |