# K023002: Clearfil AP-X PLT

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Oct 25, 2002 after 46 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: 2 generations back to K943168 (1994). 2 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001)

## Most influential descendants
- K042124: Denfil (2004), 4 descendants of its own
- K192510: DIAFIL & DIAFIL Capsule (2020), 2 descendants of its own
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own
- K261093: Diafil (2026), 0 descendants of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## Indications for use
CLEARFIL AP-X PLT 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/K023002
Methodology: https://510kreport.com/methodology