# K100328: Clearfil Majety Posterior

- Pathway: 510(k) (Special)
- Applicant: Kuraray Medical, Inc.
- Decided: Mar 5, 2010 after 29 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: 9 generations back to K931812 (1993). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063595: Clearfil Majesty Posterior, Kuraray America, Inc. (2007) Summary page 1.

## Indications for use
1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

Source page: https://510kreport.com/device/K100328
Methodology: https://510kreport.com/methodology