K093894 is an FDA 510(k) clearance for the ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE. 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 March 3, 2010, 75 days after receiving the submission on December 18, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K093894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2009 |
| Decision Date | March 03, 2010 |
| Days to Decision | 75 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 |