# K240743: Peak Universal Bond

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Mar 20, 2024 after 2 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: 10 generations back to K900510 (1990). 44 ancestors in all.
1 later device descends 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)
- K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine), Ultradent Products, Inc. (2010) Summary page 4.
- K230465: Hi-Bond Universal, Mediclus Co., Ltd. (2023) Summary page 4.

## Most influential descendants
- K262252: MPa Max adhesive (2026), 0 descendants of its own

## Indications for use
Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure. Peak Universal Bond adhesive bonds to the following materials: * Dentin and Enamel * Porcelain, Zirconia * Metal * Composite

Source page: https://510kreport.com/device/K240743
Methodology: https://510kreport.com/methodology