FDA · official record K121915Substantially Equivalent

BRIGHT RESTORATIVE MATERIALS

Name: BRIGHT RESTORATIVE MATERIALS — FDA K121915
Creator: Dmp, Ltd.
Keywords: BRIGHT RESTORATIVE MATERIALS, BRIGHT RESTORATIVE MATERIALS, K121915, EBF, FDA

United StatesEBFDmp, Ltd.

Verified

Official record identity

FDA application number: K121915
Decision date: September 28, 2012
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Dmp, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-07-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.