Submission Details
| 510(k) Number | K874335 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 1987 |
| Decision Date | December 29, 1987 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K874335 is an FDA 510(k) clearance for the EXPLORER-DENTAL PROBER. This device is classified as a Burnisher, Operative (Class I — General Controls, product code EKJ).
Submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 29, 1987, 68 days after receiving the submission on October 22, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K874335 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 1987 |
| Decision Date | December 29, 1987 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |