# K241056: Light Cure Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Sincera Technology (Changchun) Co., Ltd.
- Decided: Jul 16, 2024 after 89 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
Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures: - Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives; - Repair of dental restorations of ceramic, composites and/or metal alloys; - Indirect dental restorations cementation applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

Source page: https://510kreport.com/device/K241056
Methodology: https://510kreport.com/methodology