# K880393: Transbond Light Cured Orthodontic Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Unitek Corp.
- Decided: Mar 31, 1988 after 62 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
No predicates in its family tree.
8 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K192682: Orthocem, Ortho Bite (2020), 1 descendant of its own
- K160782: BracePaste Adhesive (2016), 1 descendant of its own
- K250015: Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (2025), 0 descendants of its own
- K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (2022), 0 descendants of its own
- K210115: FiteBac CC OrthoSeal (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K880393
Methodology: https://510kreport.com/methodology