FDA · official record K982927Substantially Equivalent

QUICK TAP SELF DRILLING SCREW

Name: QUICK TAP SELF DRILLING SCREW — FDA K982927
Creator: Kinamed, Inc.
Keywords: QUICK TAP SELF DRILLING SCREW, QUICK TAP SELF DRILLING SCREW, K982927, DZL, FDA

United StatesDZLKinamed, Inc.

Verified

Official record identity

FDA application number: K982927
Decision date: September 08, 1998
Published decision: Substantially Equivalent

Classification

Product code: DZL

Published parties

Applicant: Kinamed, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 1998-08-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4880

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.