# K012442: Modification to Clearfil SE Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 10, 2001 after 41 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: 6 generations back to K931812 (1993). 16 ancestors in all.
60 later devices descend from it; 10 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990040: Clearfil SE Bond, Kuraray Co. (1999) Summary page 1.

## Most influential descendants
- K032455: Panavia F 2.0 (2003), 34 descendants of its own
- K094007: Unicem (2010), 22 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own
- K063593: Clearfil Majesty Flow (2007), 17 descendants of its own
- K042929: Estenia C&B (2004), 12 descendants of its own

## Indications for use
CLEAFIL SE BOND is indicated for the following applications: Direct filling restorations using light-curing composite or compomer Cavity sealing as a pretreatment for indirect restorations Treatment of hypersensitive and/or exposed root surfaces Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Source page: https://510kreport.com/device/K012442
Methodology: https://510kreport.com/methodology