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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 K212577
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 Melissa Burbage
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/16/2021
Decision Date 12/10/2021
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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