K090676 is an FDA 510(k) clearance for the MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES. This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).
Submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on May 22, 2009, 70 days after receiving the submission on March 13, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K090676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2009 |
| Decision Date | May 22, 2009 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFA - Handpiece, Belt And/or Gear Driven, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |