# K043170: Bosworth Bond

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Feb 25, 2005 after 101 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives- It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond. Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. If the tooth enamel surface is kept moist to slightly wet, then only the Part B component needs to be used.

Source page: https://510kreport.com/device/K043170
Methodology: https://510kreport.com/methodology