The following data is part of a premarket notification filed by Hager& Meisinger Gmbh with the FDA for Dental Implants Oktagon Bone Level Tapered Design.
| Device ID | K170287 |
| 510k Number | K170287 |
| Device Name: | Dental Implants OKTAGON Bone Level Tapered Design |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hager& Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Contact | Melanie May |
| Correspondent | Melanie May 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 | 2017-01-30 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950028566 | K170287 | 000 |
| 00614950028559 | K170287 | 000 |
| 00614950028542 | K170287 | 000 |
| 00614950028535 | K170287 | 000 |