# K200153: Bright Bond Universal

- Pathway: 510(k) (Traditional)
- Applicant: Genoss Co., Ltd.
- Decided: Oct 28, 2020 after 280 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: 7 generations back to K900510 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.

## Indications for use
1) Direct bonding for light-cured composites to tooth surface 2) Bonding of dual-cured core build up composites to tooth surface 3) Intraoral repair of composite, PFM and ceramic restoration using cements 4) Sealing of tooth preparation for indirect restoration

Source page: https://510kreport.com/device/K200153
Methodology: https://510kreport.com/methodology