# K230465: Hi-Bond Universal

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: May 22, 2023 after 90 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: 9 generations back to K900510 (1990). 43 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161051: All-Bond Universal w/BAC (not finalized), Bisco, Inc. (2016) Summary page 4.

## Most influential descendants
- K240743: Peak Universal Bond (2024), 1 descendant of its own
- K262252: MPa Max adhesive (2026), 0 descendants of its own

## Indications for use
1. all direct restorations 2. all indirect restorations 3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites) 4. desensitizing/sealing of tooth structure 5. protective varnish for glass ionomer fillings 6. priming of enamel for orthodontic use

Source page: https://510kreport.com/device/K230465
Methodology: https://510kreport.com/methodology