FDA · official record K950624Substantially Equivalent

HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

Name: HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM — FDA K950624
Creator: Lifecore Biomedical, Inc.
Keywords: HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM, HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM, K950624, DZE, FDA

United StatesDZELifecore Biomedical, Inc.

Verified

Official record identity

FDA application number: K950624
Decision date: August 30, 1995
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: 1995-02-10
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.