# K201787: Light Cure Dental Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Sep 25, 2020 after 87 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
Longest line of descent: 8 generations back to K900510 (1990). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112118: Dreambond, Bisco, Inc. (2011) Summary page 4.

## Indications for use
Light Cure Dental 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, mental-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

Source page: https://510kreport.com/device/K201787
Methodology: https://510kreport.com/methodology