The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant Oktagon Bone Level.
| Device ID | K143539 |
| 510k Number | K143539 |
| Device Name: | Dental Implant OKTAGON Bone Level |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Contact | Wiebke Stolten |
| Correspondent | Wiebke Stolten Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-08-31 |
| Summary: | summary |