FDA · official record K970776Substantially Equivalent

LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT

Name: LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT — FDA K970776
Creator: Lifecore Biomedical, Inc.
Keywords: LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT, LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT, K970776, DZE, FDA

United StatesDZELifecore Biomedical, Inc.

Verified

Official record identity

FDA application number: K970776
Decision date: May 27, 1997
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Lifecore Biomedical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-03-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.