FDA · official record K982488Substantially Equivalent

BICON BONE SCREW SYSTEM

Name: BICON BONE SCREW SYSTEM — FDA K982488
Creator: Bicon, Inc.
Keywords: BICON BONE SCREW SYSTEM, BICON BONE SCREW SYSTEM, K982488, DZE, FDA

United StatesDZEBicon, Inc.

Verified

Official record identity

FDA application number: K982488
Decision date: January 26, 1999
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Bicon, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-07-17
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.