# K020394: Apc Plus Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: 3M Unitek
- Decided: Apr 12, 2002 after 65 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.
6 later devices descend from it; 4 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061252: Pre-Cemented Orthodontic Bracket System (2007), 2 descendants of its own
- K081291: Pre-Cemented Orthodontic Bracket System Extension (2008), 1 descendant of its own
- K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (2022), 0 descendants of its own
- K113197: Apc Flash-Free Adhesive (2012), 0 descendants of its own
- K093221: Pre-Cemented Orthodontic Bracket System Extension II (2009), 0 descendants of its own

## Indications for use
3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.

Source page: https://510kreport.com/device/K020394
Methodology: https://510kreport.com/methodology