# K093221: Pre-Cemented Orthodontic Bracket System Extension II

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl., Inc.
- Decided: Oct 30, 2009 after 17 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: 4 generations back to K852179 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
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.
- K081291: Pre-Cemented Orthodontic Bracket System Extension, Dentsply Interntional (2008) Summary page 1.

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

Source page: https://510kreport.com/device/K093221
Methodology: https://510kreport.com/methodology