FDA · official record K093749Substantially Equivalent

GC AADVA IMPLANT SYSTEM

Name: GC AADVA IMPLANT SYSTEM — FDA K093749
Creator: GC America, Inc.
Keywords: GC AADVA IMPLANT SYSTEM, GC AADVA IMPLANT SYSTEM, K093749, DZE, FDA

United StatesDZEGC America, Inc.

Verified

Official record identity

FDA application number: K093749
Decision date: December 06, 2010
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: GC America, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2009-12-07
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.