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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 K252904
Device Name SIC Abutments including CAD/CAM Solutions
Applicant
Sic Invent AG
Birmanngasse 3
Basel,  CH CH-4055
Applicant Contact Marcus von Malottki
Correspondent
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad,  CA  92008
Correspondent Contact Kevin Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/11/2025
Decision Date 06/03/2026
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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