The following data is part of a premarket notification filed by Medical Instinct Deutschland Gmbh with the FDA for Bonetrust Mini Implant System.
| Device ID | K200573 | 
| 510k Number | K200573 | 
| Device Name: | BoneTrust Mini Implant System | 
| Classification | Implant, Endosseous, Root-form | 
| Applicant | Medical Instinct Deutschland GmbH Graseweg 24 Bovenden, DE 37120 | 
| Contact | Jan Worlitz | 
| Correspondent | André Weingerl WRC Consulting Am Hohstetter 1a Steißlingen, DE 78256  | 
| Product Code | DZE | 
| CFR Regulation Number | 872.3640 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Abbreviated | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2020-03-05 | 
| Decision Date | 2021-05-14 |