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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 K252384
Device Name DESS® Dental Smart Solutions
Applicant
Terrats Medical SL
Carrer Mogoda 75-99
Barberá Del Vallés,  ES 08210
Applicant Contact Roger Terrats
Correspondent
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad,  CA  92008
Correspondent Contact Rebecca Kattan
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/31/2025
Decision Date 10/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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