# K023776: Xeno Iii Dental Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jan 23, 2003 after 72 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: 5 generations back to K931812 (1993). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own
- K061427: Pre-Impression Conditioning Solution (2006), 0 descendants of its own

## Indications for use
Dental adhesive for direct light-cured composite restorative materials

Source page: https://510kreport.com/device/K023776
Methodology: https://510kreport.com/methodology