FDA · official record K073032Substantially Equivalent

PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS

Name: PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS — FDA K073032
Creator: Lifecore Biomedical, Inc.
Keywords: PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS, PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS, K073032, NHA, FDA

United StatesNHALifecore Biomedical, Inc.

Verified

Official record identity

FDA application number: K073032
Decision date: November 16, 2007
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Lifecore Biomedical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2007-10-26
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.