FDA · official record K142886Substantially Equivalent

DMRC Self-Cure Bracket Adhesive One Step and Primer

Name: DMRC Self-Cure Bracket Adhesive One Step and Primer — FDA K142886
Creator: Danville Materials, LLC
Keywords: DMRC Self-Cure Bracket Adhesive One Step and Primer, DMRC Self-Cure Bracket Adhesive One Step and Primer, K142886, DYH, FDA

United StatesDYHDanville Materials, LLC

Verified

Official record identity

FDA application number: K142886
Decision date: March 18, 2015
Published decision: Substantially Equivalent

Classification

Product code: DYH

Published parties

Applicant: Danville Materials, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2014-10-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3750

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.