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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 K182313
Device Name BoneTrust Implant System
Applicant
Medical Instinct Deutschland GmbH
Graseweg 24
Bovenden,  DE 37120
Applicant Contact Jan Worlitz
Correspondent
Wrc Consulting
Am Hohsetter 1a
Steislingen,  DE
Correspondent Contact Andre Weingerl
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/27/2018
Decision Date 03/11/2019
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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