The following data is part of a premarket notification filed by Medical Instinct Deutschland Gmbh with the FDA for Bonetrust Implant System.
| Device ID | K182313 |
| 510k Number | K182313 |
| Device Name: | BoneTrust Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Medical Instinct Deutschland GmbH Graseweg 24 Bovenden, DE 37120 |
| Contact | Jan Worlitz |
| Correspondent | Andre Weingerl WRC Consulting Am Hohsetter 1A Steislingen, DE |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2019-03-11 |