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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 K210220
Device Name Kontact Dental Implant System
Applicant
BIOTECH DENTAL, SAS
305 Allées De Craponne
Salon De Provence,  FR 13300
Applicant Contact Delphine Mercier
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/27/2021
Decision Date 06/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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