K925115 is an FDA 510(k) clearance for the AMD DENTIST AND HYGIENIST KITS. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on July 5, 1994, 634 days after receiving the submission on October 9, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K925115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1992 |
| Decision Date | July 05, 1994 |
| Days to Decision | 634 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |