BoneTrust Mini Implant System

Implant, Endosseous, Root-form

Medical Instinct Deutschland GmbH

The following data is part of a premarket notification filed by Medical Instinct Deutschland Gmbh with the FDA for Bonetrust Mini Implant System.

Pre-market Notification Details

Device IDK200573
510k NumberK200573
Device Name:BoneTrust Mini Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Medical Instinct Deutschland GmbH Graseweg 24 Bovenden,  DE 37120
ContactJan Worlitz
CorrespondentAndré Weingerl
WRC Consulting Am Hohstetter 1a Steißlingen,  DE 78256
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2021-05-14

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