# K041343: Xeno NM Light Cured Dental Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Jun 16, 2004 after 27 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.
2 later devices descend from it; 1 cites it directly.
0 of 11 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
- K051463: Xeno Adhesive with Activator (2005), 1 descendant of its own
- K151619: Prime&Bond Elect Universal Dental Adhesive (2015), 0 descendants of its own

## Indications for use
XENO® NM Light Cured Dental Adhesive is indicated for: Direct composite and compomer restorations for all cavity classes in anterior and posterior teeth Veneers Composite, ceramic and metal repairs Cavity varnish for use with fresh amalgam

Source page: https://510kreport.com/device/K041343
Methodology: https://510kreport.com/methodology