# K012440: Modification to Clearfil Liner Bond 2V

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 5, 2001 after 36 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: 5 generations back to K931812 (1993). 14 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974486: Clearfil Liner Bond  2V, Kuraray America, Inc. (1998) Summary page 1.

## Most influential descendants
- K062382: Clearfil DC Bond (2006), 6 descendants of its own
- K111980: Clearfil Tri-S Bond Plus (2011), 4 descendants of its own
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond (2013), 1 descendant of its own
- K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil (2013), 1 descendant of its own

## Indications for use
CLEAFIL LINER BOND 2V is indicated for the following applications: Direct filling restorations using light-cure or chemical-cure composite resin Bonded amalgam restorations Treatment of hypersensitive and/or exposed root surfaces Cavity sealing as a pretreatment for indirect restorations Intraoral repairs of facing crowns using light-cure composite resin Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

Source page: https://510kreport.com/device/K012440
Methodology: https://510kreport.com/methodology