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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 K203660
Device Name TRI-matrix Implant Line
Applicant
TRI Dental Implants Int. AG
Boesch 80A / Postfach 419
Huenenberg,  CH 6331
Applicant Contact Sandro Venanzoni
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Floyd G. Larson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/15/2020
Decision Date 12/21/2021
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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