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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 K240982
Device Name DESS Dental Smart Solutions
Applicant
Terrats Medical SL
Mogoda, 75
Barbera Del Valles
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 Received04/10/2024
Decision Date 08/26/2024
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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