# K051463: Xeno Adhesive with Activator

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 12, 2005 after 39 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: 6 generations back to K931812 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites 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)
- K041343: Xeno NM Light Cured Dental Adhesive, Dentsply International (2004) Summary page 1.
- K050386: Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System, Dentsply International (2005) Summary page 1.

## Most influential descendants
- K151619: Prime&Bond Elect Universal Dental Adhesive (2015), 0 descendants of its own

## Indications for use
XENO® ADHESIVE WITH ACTIVATOR is indicated for: * direct, light-cured composite and compomer restorations; - indirect restorations; * light-cured resin cemented veneers; * composite, ceramic, and amalgam repairs; * cavity varnish for use with fresh amalgam; * direct, dual-cure or self-cure composite restorations and core build-ups; * resin cemented inlays, onlays, crown and bridge retainers, and endodontic post cementation; and * adhesive bonding of direct amalgam restorations.

Source page: https://510kreport.com/device/K051463
Methodology: https://510kreport.com/methodology