# K012734: Clearfil New Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 14, 2001 after 31 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 K943167 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943167: Clearfil New Bond, Kuraray Company, Ltd. (1994) Summary page 1.

## Most influential descendants
- K131430: Clearfil DC Activator; Clearfil DC Activator Trial (2013), 0 descendants of its own

## Indications for use
CLEAFIL NEW 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/K012734
Methodology: https://510kreport.com/methodology