# K142886: DMRC Self-Cure Bracket Adhesive One Step and Primer

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, LLC
- Decided: Mar 18, 2015 after 167 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941015 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941015: Ormco System 1+ (TM), Ormco Corp. (1994) Summary page 4.

## Indications for use
This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure

Source page: https://510kreport.com/device/K142886
Methodology: https://510kreport.com/methodology