K061383 is an FDA 510(k) clearance for the BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).
Submitted by B.T.I. Biotechnology Institute, Sl. (Minano(Alava), ES). The FDA issued a Cleared decision on August 3, 2006, 77 days after receiving the submission on May 18, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.
| 510(k) Number | K061383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2006 |
| Decision Date | August 03, 2006 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJL — Bur, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3240 |