510(k) K142886

DMRC Self-Cure Bracket Adhesive One Step and Primer by Danville Materials, LLC — Product Code DYH

K142886 is an FDA 510(k) premarket notification submitted by Danville Materials, LLC for the device "DMRC Self-Cure Bracket Adhesive One Step and Primer". The FDA issued a decision of Substantially Equivalent on March 18, 2015. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Danville Materials, LLC has at least 10 other 510(k) clearances on record.