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 |