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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 K122295
Device Name CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
Applicant
CORE 3D PROTECH, S.L.
POL. IND. SANTA ANNA
APARTAT 20
SANTPEDOR,  ES 08251
Applicant Contact ANNA CORTINA
Correspondent
CORE 3D PROTECH, S.L.
POL. IND. SANTA ANNA
APARTAT 20
SANTPEDOR,  ES 08251
Correspondent Contact ANNA CORTINA
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/31/2012
Decision Date 10/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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