# K214054: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

- Pathway: 510(k) (Traditional)
- Applicant: Tp Orthodontics, Inc.
- Decided: Oct 14, 2022 after 291 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 K031915 (2003). 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)
- K160782: BracePaste Adhesive, American Orthodontics (2016) Summary page 4.
- K020394: Apc Plus Adhesive, 3M Unitek (2002) Summary page 4.
- K172953: Acid Etchant, American Orthodontics (2018) Summary page 4.

## Indications for use
TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment. TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Source page: https://510kreport.com/device/K214054
Methodology: https://510kreport.com/methodology