K851713 is an FDA 510(k) clearance for the 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA. This device is classified as a Elevator, Surgical, Dental (Class I - General Controls, product code EMJ).
Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 11, 1985, 47 days after receiving the submission on April 25, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K851713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1985 |
| Decision Date | June 11, 1985 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMJ — Elevator, Surgical, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |