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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 K230143
Device Name DESS Dental Smart Solutions
Applicant
Terrats Medical SL
Carrer Mogoda 75-99
Barbera del Valles,  ES 08210
Applicant Contact Roger Terrats
Correspondent
PaxMed International, LLC
12264 EL Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/18/2023
Decision Date 04/13/2023
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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