# K001913: Clearfil ST Opaquer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Aug 4, 2000 after 42 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K012704: Clearfil ST Opaquer (2001), 5 descendants of its own
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own
- K162967: nuance UNIVERSAL (2017), 0 descendants of its own
- K100328: Clearfil Majety Posterior (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K001913
Methodology: https://510kreport.com/methodology