K945815 is an FDA 510(k) clearance for the DENTAL KIT. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Constancy Ent., Inc. (San Gabriel, US). The FDA issued a Cleared decision on July 19, 1995, 233 days after receiving the submission on November 28, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K945815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1994 |
| Decision Date | July 19, 1995 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |