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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 K250639
Device Name DESS Dental Smart Solutions
Applicant
Terrats Medical SL
Carrer Mogoda 75-99
Barberà Del Vallès
Barcelona,  ES 08210
Applicant Contact Roger Terrats
Correspondent
Enerxen Consulting, Inc.
1155 Metcalfe St., Suite 1572
Montreal,  CA H3B2V6
Correspondent Contact Melissa Burbage
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received03/03/2025
Decision Date 05/22/2025
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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