# K001914: Clearfil Repair

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Aug 10, 2000 after 48 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own
- K012729: Clearfil Repair (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K001914
Methodology: https://510kreport.com/methodology