# K210804: Adhese Universal DC, Cention Primer

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jun 7, 2022 after 447 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: 8 generations back to K900510 (1990). 37 ancestors in all.
1 later device descends 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)
- K133318: Adhese Universal, Ivoclar Vivadent, AG (2014) Summary page 4.

## Most influential descendants
- K252450: Adhese 2 (2026), 0 descendants of its own

## Indications for use
Missing tooth structure Defective restorations

Source page: https://510kreport.com/device/K210804
Methodology: https://510kreport.com/methodology