The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implants Oktagon Tissue Level And Bone Level.
| Device ID | K162073 |
| 510k Number | K162073 |
| Device Name: | Dental Implants OKTAGON Tissue Level And Bone Level |
| 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 | 2016-07-27 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDRS311501 | K162073 | 000 |
| E0HM220511 | K162073 | 000 |
| E0HM220521 | K162073 | 000 |
| E0HM311401 | K162073 | 000 |
| E0HM311411 | K162073 | 000 |
| E0HM311421 | K162073 | 000 |
| E0HM311501 | K162073 | 000 |
| EDRS220501 | K162073 | 000 |
| EDRS220511 | K162073 | 000 |
| EDRS220521 | K162073 | 000 |
| EDRS311401 | K162073 | 000 |
| EDRS311411 | K162073 | 000 |
| EDRS311421 | K162073 | 000 |
| E0HM220501 | K162073 | 000 |