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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K203464
Device Name DESS Dental Smart Solutions
Terrats Medical SL
Carrer Mogoda 75-99
Barbera del Valles,  ES 08210
Applicant Contact Roger Terrats
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Floyd G. Larson
Regulation Number872.3630
Classification Product Code
Date Received11/24/2020
Decision Date 08/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No