K041279 is an FDA 510(k) clearance for the IMPLANTEO IMPLANTOLOGY MOTOR. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on September 23, 2004, 133 days after receiving the submission on May 13, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K041279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2004 |
| Decision Date | September 23, 2004 |
| Days to Decision | 133 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |