# K012730: Clearfil Porcelain Bond Activator

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 13, 2001 after 30 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: 1 generation back to K925404 (1993). 1 ancestor in all.
11 later devices descend from it; 2 cite 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)
- K925404: Clearfil Porcelain Bond Activator, Kuraray Co. (1993) Summary page 1.

## Most influential descendants
- 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
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond (2013), 1 descendant of its own

## Indications for use
CLEAFIL PORCELAIN BOND ACTIVATOR is indicated for the following applications: 1) Repair of porcelain or porcelain fused-to-metal crowns and bridges 2) Restoration of gingival porcelain areas where bonding to porcelain is necessary 3) Increased retention of porcelain inlays, onlays, crowns and veneers 4) Increased retention of composite inlays and onlays

Source page: https://510kreport.com/device/K012730
Methodology: https://510kreport.com/methodology