# K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Aug 22, 2013 after 97 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: 9 generations back to K931812 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 1.
- K062382: Clearfil DC Bond, Kuraray Medical, Inc. (2006) Summary page 1.
- K101423: Optibond XTR, Kerr Corporation (2010) Summary page 1.
- K111980: Clearfil Tri-S Bond Plus, Kuraray America, Inc. (2011) Summary page 1.
- K043177: Cleafil DC Core Automix, Kuraray Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (2023), 0 descendants of its own

## Indications for use
[I] Direct restorations using light-cured composite resin [2] Cavity sealing as a pretreatment for indirect restorations [3] Treatment of exposed root surfaces [4] Treatment of hypersensitive teeth [5] Intraoral repairs of fractured restorations [6] Post cementation using a dual- or self-cured composite resin [7] Core build-ups using a light-, dual- or self-cured core material [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement

Source page: https://510kreport.com/device/K131432
Methodology: https://510kreport.com/methodology