# K061252: Pre-Cemented Orthodontic Bracket System

- Pathway: 510(k) (Traditional)
- Applicant: Primus Consulting
- Decided: Feb 12, 2007 after 284 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 K020394 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020394: Apc Plus Adhesive, 3M Unitek (2002) Summary page 1.

## Most influential descendants
- K081291: Pre-Cemented Orthodontic Bracket System Extension (2008), 1 descendant of its own
- K093221: Pre-Cemented Orthodontic Bracket System Extension II (2009), 0 descendants of its own

## Indications for use
Indicated for use in bonding orthodontic appliances for orthodontic treatment

Source page: https://510kreport.com/device/K061252
Methodology: https://510kreport.com/methodology