The following data is part of a premarket notification filed by Medentika Gmbh with the FDA for Medentika Cad/cam Abutments.
| Device ID | K150203 |
| 510k Number | K150203 |
| Device Name: | Medentika CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MEDENTIKA GMBH HAMMWEG 8-10 Huegelsheim, DE 76549 |
| Contact | Dr. Gerhard Polzer |
| Correspondent | Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-10-23 |
| Summary: | summary |