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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 K213997
Device Name Kontact Dental Implant System
Applicant
Biotech Dental, Sas
305, Allées De Craponne
Salon De Provence,  FR 13300
Applicant Contact Delphine Mercier
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/21/2021
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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