# K262252: MPa Max adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: Sep 24, 2026 after 84 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: 11 generations back to K900510 (1990). 45 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K240743: Peak Universal Bond, Ultradent Products, Inc. (2024) Summary page 5.

## Indications for use
Use for virtually all bonding needs in restorative dentistry for dental patients of all ages. MPa Max adhesive bonds to the following materials: • Dentin and enamel • Porcelain (hydrofluoric acid and silane required) • Zirconia • Metal • Composite

Source page: https://510kreport.com/device/K262252
Methodology: https://510kreport.com/methodology