# K181476: Prime&Bond active Universal Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 28, 2018 after 115 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: 7 generations back to K900510 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.

## Indications for use
Direct, light cured composite and compomer restorations. Light cured resin cemented veneers. Composite, ceramic and amalgam repairs. Cavity varnish for use with fresh amalgam. Indirect restorations and endodontic posts cemented with Calibra® Ceram. Desensitization of exposed dentin. Surface treatment of zirconia, metal. and composite. In combination with DENTSPLY Self Cure Activator: Direct dual cure / self-cure composite restorations and core build-ups. Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.

Source page: https://510kreport.com/device/K181476
Methodology: https://510kreport.com/methodology