# K925404: Clearfil Porcelain Bond Activator

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Co.
- Decided: Jan 11, 1993 after 80 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012730: Clearfil Porcelain Bond Activator (2001), 11 descendants of its own
- K061906: Clearfil Ceramic Primer (2006), 9 descendants of its own
- K024356: Clearfil Silane Kit (2003), 4 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K925404
Methodology: https://510kreport.com/methodology