K926368 is an FDA 510(k) clearance for the APPLICATOR NOZZLE. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 15, 1993, 267 days after receiving the submission on December 22, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K926368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1992 |
| Decision Date | September 15, 1993 |
| Days to Decision | 267 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 |