FDA · official record K070854Substantially Equivalent

GC MI PASTE PLUS

Name: GC MI PASTE PLUS — FDA K070854
Creator: GC America, Inc.
Keywords: GC MI PASTE PLUS, GC MI PASTE PLUS, K070854, EJR, FDA

United StatesEJRGC America, Inc.

Verified

Official record identity

FDA application number: K070854
Decision date: April 12, 2007
Published decision: Substantially Equivalent

Classification

Product code: EJR

Published parties

Applicant: GC America, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2007-03-28
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6030

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.