# K022999: Clearfil AP-X PLT Intro Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Oct 24, 2002 after 45 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: 7 generations back to K931812 (1993). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 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) Summary page 1.
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001)

## Indications for use
CLEARFIL AP-X PLT INTRO KIT 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/K022999
Methodology: https://510kreport.com/methodology