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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 K151916
Device Name TRI Dental Implant System
Applicant
TRI DENTAL IMPLANTS INT. AG
LINDENSTRASSE 14
baar,  CH ch-6340
Applicant Contact sandro venanzoni
Correspondent
PAXMED INTERNATIONAL, LLC
12264 EL CAMINO REAL, SUITE 400
san diego,  CA  92130
Correspondent Contact linda schulz
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/13/2015
Decision Date 12/18/2015
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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