The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant Abutment Oktagon Bone Level Rc, Dental Implant Abutment Oktagon Bone Level Nc.
| Device ID | K160132 |
| 510k Number | K160132 |
| Device Name: | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950026999 | K160132 | 000 |
| EDRS221031 | K160132 | 000 |
| EDRS220421 | K160132 | 000 |
| EDRS220411 | K160132 | 000 |
| EDRS220261 | K160132 | 000 |
| EDRS220251 | K160132 | 000 |
| E0HM221311 | K160132 | 000 |
| E0HM221301 | K160132 | 000 |
| E0HM221291 | K160132 | 000 |
| E0HM221051 | K160132 | 000 |
| E0HM221031 | K160132 | 000 |
| E0HM220421 | K160132 | 000 |
| E0HM220411 | K160132 | 000 |
| E0HM220261 | K160132 | 000 |
| EDRS221051 | K160132 | 000 |
| EDRS221291 | K160132 | 000 |
| 00614950026982 | K160132 | 000 |
| 00614950026975 | K160132 | 000 |
| 00614950026968 | K160132 | 000 |
| 00614950026951 | K160132 | 000 |
| 00614950026944 | K160132 | 000 |
| 00614950026937 | K160132 | 000 |
| 00614950026920 | K160132 | 000 |
| E0HM50221051 | K160132 | 000 |
| E0HM50221031 | K160132 | 000 |
| E0HM50220261 | K160132 | 000 |
| E0HM50220251 | K160132 | 000 |
| EDRS221311 | K160132 | 000 |
| EDRS221301 | K160132 | 000 |
| E0HM220251 | K160132 | 000 |