FDA · official record K924589Substantially Equivalent

RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

Name: RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM — FDA K924589
Creator: Implant Support Systems, Inc.
Keywords: RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM, RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM, K924589, DZE, FDA

United StatesDZEImplant Support Systems, Inc.

Verified

Official record identity

FDA application number: K924589
Decision date: June 22, 1994
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Implant Support Systems, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1992-09-10
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.