K851715 is an FDA 510(k) clearance for the 830/4 TO 848/7 VARIOUS TYPES CHISELS. This device is classified as a Chisel, Bone, Surgical (Class I - General Controls, product code EML).
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 | K851715 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 | EML — Chisel, Bone, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |