# K213965: BeautiBond Xtreme

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Mar 18, 2022 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K231039: CLEARFIL Universal Bond Quick 2 (2023), 0 descendants of its own

## Indications for use
Direct restorations with light-cured composite resin Repair of fractured restorations with light-cured composite resin Post cementation and core build-up Cementation of indirect restorations with light-cured/dual-cured resin cement Treatment of hypersensitive teeth or exposed root surface Sealing of tooth preparation (cavity or abutment) for indirect restorations

Source page: https://510kreport.com/device/K213965
Methodology: https://510kreport.com/methodology