The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Aarhus Anchorage System.
| Device ID | K041527 |
| 510k Number | K041527 |
| Device Name: | AARHUS ANCHORAGE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEDICON, E.G. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell MEDICON, E.G. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-08 |
| Decision Date | 2004-08-19 |
| Summary: | summary |