# K070538: XP Bond Dual Cure Universal Total Etch Adhesive

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: Mar 14, 2007 after 16 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: 1 generation back to K050386 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050386: Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System, Dentsply International (2005) Summary page 1.

## Indications for use
XP BOND is indicated for 1. Direct, Light-cured composite and compomer restorative. 2. Indirect Restorations; Light-cured, resin cemented Veneers. 3. Composite, ceramic and amalgam repairs. 4. Cavity varnish for use with fresh amalgam. 5. Direct, dual cure or self-cure composite restorations and core build-ups. 6. Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers. 7. Dual cured and self cured resin cemented Endodontic post cementation. 8. Adhesive bonding of direct amalgam restoration.

Source page: https://510kreport.com/device/K070538
Methodology: https://510kreport.com/methodology