The following data is part of a premarket notification filed by Medentika Gmbh with the FDA for Minicone Implant.
| Device ID | K200906 |
| 510k Number | K200906 |
| Device Name: | MINICONE Implant |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Medentika GmbH Hammweg 8-10 Huegelsheim, DE 76549 |
| Contact | Alexandra Schulz |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMKA501099 | K200906 | 000 |
| EMKA501089 | K200906 | 000 |