# K081291: Pre-Cemented Orthodontic Bracket System Extension

- Pathway: 510(k) (Special)
- Applicant: Dentsply Interntional
- Decided: May 22, 2008 after 15 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: 3 generations back to K852179 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061252: Pre-Cemented Orthodontic Bracket System, Primus Consulting (2007) Summary page 1.
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 1.

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

## Indications for use
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.

Source page: https://510kreport.com/device/K081291
Methodology: https://510kreport.com/methodology