# K012432: Modification to Clearfil Photo Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 4, 2001 after 35 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 K943165 (1994). 1 ancestor in all.
48 later devices descend from it; 5 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) 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
- K062410: Clearfil Esthetic Cement & DC Bond (2006), 10 descendants of its own
- K081583: Clearfil SA Cement (2008), 9 descendants of its own

## Indications for use
CLEARFIL PHOTO BOND is indicated for the following applications: 1) A dentin and enamel bonding system for composite resin restoration 2) A dentin and enamel bonding system for amalgam restoration

Source page: https://510kreport.com/device/K012432
Methodology: https://510kreport.com/methodology