FDA · official record K122295Substantially Equivalent

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS

Name: CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS — FDA K122295
Creator: Core 3D Protech, S.L.
Keywords: CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS, CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS, K122295, NHA, FDA

United StatesNHACore 3D Protech, S.L.

Verified

Official record identity

FDA application number: K122295
Decision date: October 24, 2013
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Core 3D Protech, S.L.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2012-07-31
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.