# K070325: Clearfil Majesty Esthetic PLT

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Mar 21, 2007 after 44 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: 3 generations back to K943168 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061860: Clearfil Majesty Esthetic, Kuraray Medical, Inc. (2006) Summary page 1.
- K023002: Clearfil AP-X PLT, Kuraray Medical, Inc. (2002) Summary page 1.

## Indications for use
CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications: 1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Direct veneers 3) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 4) Intraoral repairs of fractured crowns/bridges

Source page: https://510kreport.com/device/K070325
Methodology: https://510kreport.com/methodology