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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K200573
Device Name BoneTrust Mini Implant System
Applicant
Medical Instinct Deutschland GmbH
Graseweg 24
Bovenden,  DE 37120
Applicant Contact Jan Worlitz
Correspondent
Wrc Consulting
Am Hohstetter 1a
Steißlingen,  DE 78256
Correspondent Contact André Weingerl
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/05/2020
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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