FDA 510(k) Application Details - K122295

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K122295
Device Name Abutment, Implant, Dental, Endosseous
Applicant CORE 3D PROTECH, S.L.
POL. IND. SANTA ANNA
APARTAT 20
SANTPEDOR 08251 ES
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Contact ANNA CORTINA
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/31/2012
Decision Date 10/24/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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