The following data is part of a premarket notification filed by Medentika Gmbh with the FDA for Medentika Abutment System, Medentika Cad/cam Abutments, Medentika Cad/cam Tibases.
| Device ID | K180564 |
| 510k Number | K180564 |
| Device Name: | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Medentika GmbH Hammweg 8-10 Huegelsheim, DE 76549 |
| Contact | Gerhard Polzer |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2019-01-07 |
| Summary: | summary |