# K943168: Clearfil AP-X

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Company, Ltd.
- Decided: Aug 10, 1994 after 40 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.
130 later devices descend from it; 3 cite it directly.
0 of 131 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
- K984201: Denzir (1999), 93 descendants of its own
- K023327: Cynovad Zirkon (2002), 91 descendants of its own
- K043472: Medin Tech Zirconia-CP10, SS1000 (2005), 80 descendants of its own
- K062695: Sagemax Z-Blank (2006), 76 descendants of its own
- K081850: Bisque Zirconia Blanks, Type Byz (2008), 43 descendants of its own

Source page: https://510kreport.com/device/K943168
Methodology: https://510kreport.com/methodology