# K012740: Clearfil AP-X

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 14, 2001 after 31 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
Longest line of descent: 1 generation back to K943168 (1994). 1 ancestor in all.
35 later devices descend from it; 11 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943168: Clearfil AP-X, Kuraray Company, Ltd. (1994) Summary page 1.

## Most influential descendants
- K063593: Clearfil Majesty Flow (2007), 17 descendants of its own
- K061860: Clearfil Majesty Esthetic (2006), 11 descendants of its own
- K023002: Clearfil AP-X PLT (2002), 9 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own

## Indications for use
CLEARFIL AP-X is indicated for the following applications: 1) Class I, II, V restorations of posterior teeth 2) Class III, IV, V restorations of anterior teeth 3) Cervical cavities or defects involving root surfaces

Source page: https://510kreport.com/device/K012740
Methodology: https://510kreport.com/methodology