# K110252: Beautibond Multi PR Plus

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: May 13, 2011 after 105 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
BeautiBond Multi PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.

Source page: https://510kreport.com/device/K110252
Methodology: https://510kreport.com/methodology