K926081 is an FDA 510(k) clearance for the DENTAL LIGHT. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).
Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on January 26, 1994, 421 days after receiving the submission on December 1, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.
| 510(k) Number | K926081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1992 |
| Decision Date | January 26, 1994 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EAZ — Light, Operating, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4630 |