# K024356: Clearfil Silane Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Mar 26, 2003 after 86 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: 7 generations back to K931812 (1993). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 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.
- K012730: Clearfil Porcelain Bond Activator, Kuraray Medical, Inc. (2001) Summary page 1.
- K012432: Modification to Clearfil Photo Bond, Kuraray Medical, Inc. (2001)

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K180802: Meta P&Bond (2018), 0 descendants of its own

## Indications for use
CLEARFIL SILANE KIT is indicated for the following applications: 1) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite. 2) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.

Source page: https://510kreport.com/device/K024356
Methodology: https://510kreport.com/methodology