# K133318: Adhese Universal

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Feb 11, 2014 after 106 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.
2 later devices descend from it; 1 cites it directly.
0 of 39 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 1.

## Most influential descendants
- K210804: Adhese Universal DC, Cention Primer (2022), 1 descendant of its own
- K252450: Adhese 2 (2026), 0 descendants of its own

## Indications for use
Direct-placed light-curing composite and compomner restorations. Direct-placed core build-ups with light-, self- and dual-curing composites. Repair of fractured composite and compomner restorations. Adhesive cementation of indirect restorations with light- and dual-curing luting composites. Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations. Desensitization of hypersensitive cervical areas.

Source page: https://510kreport.com/device/K133318
Methodology: https://510kreport.com/methodology