K914714 is an FDA 510(k) clearance for the BONE DRILLS OR TAPS. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Implant Corp. of America (St. Petersburg, US). The FDA issued a Cleared decision on November 15, 1993, 759 days after receiving the submission on October 18, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K914714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1991 |
| Decision Date | November 15, 1993 |
| Days to Decision | 759 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |