# K943167: Clearfil New Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Aug 10, 1994 after 40 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.
70 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K974486: Clearfil Liner Bond  2V (1998), 67 descendants of its own
- K990040: Clearfil SE Bond (1999), 64 descendants of its own
- K012442: Modification to Clearfil SE Bond (2001), 60 descendants of its own
- K032455: Panavia F 2.0 (2003), 34 descendants of its own
- K094007: Unicem (2010), 22 descendants of its own

Source page: https://510kreport.com/device/K943167
Methodology: https://510kreport.com/methodology