# K220804: Dia-X Bond Universal

- Pathway: 510(k) (Special)
- Applicant: DiaDent Group International
- Decided: Jun 15, 2022 after 89 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.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213401: DIAPLUS Universal, DiaDent Group International (2022) Summary page 4.

## Indications for use
- All direct restorations - All indirect restorations - Desensitizing/sealing of tooth - Intra-oral repairs

Source page: https://510kreport.com/device/K220804
Methodology: https://510kreport.com/methodology