# K260682: Bond-PR™ Universal Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Company
- Decided: Mar 3, 2026 after 1 day
- 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: 8 generations back to K900510 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192961: ADH19, 3M Deutschland GmbH (2019) Summary page 5.

## Indications for use
Bonding of methacrylate-based light-, dual-, and self-cure composites, compomers, core build-up materials, sealants, and cements. Intraoral repair of composite and compomer restorations Root surface desensitization Cavity sealing prior to amalgam or temporary restorations Cementation of indirect restorations, including veneers, with resin cement Intraoral repair of composite, ceramic, porcelain-fused-to-metal, zirconia and other all-ceramic restorations.

Source page: https://510kreport.com/device/K260682
Methodology: https://510kreport.com/methodology