# K250673: CERABIEN MiLai

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: May 29, 2025 after 84 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K043462 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213147: CERABIEN MiLai, Kuraray Noritake Dental, Inc. (2022) Summary page 5.
- K043462: CZR Press LF, Noritake Co., Inc. (2005) Summary page 5.
- K170834: Cerabien ZR, Kuraray Noritake Dental, Inc. (2017) Summary page 5.

## Most influential descendants
- K262195: Dandy Ceramic Stain and Glaze (2026), 0 descendants of its own

## Indications for use
For use in prosthetic dentistry to create an all-ceramic prosthesis. - Ceramic for coverage of a zirconia substructure - Ceramic for coverage of a lithium disilicate substructure

Source page: https://510kreport.com/device/K250673
Methodology: https://510kreport.com/methodology