# K212548: LUXEN CL Dental Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Dentalmax Co., Ltd.
- Decided: Dec 6, 2021 after 115 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: 2 generations back to K011394 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092020: Aadva ZR Coloring Liquid, GC America, Inc. (2009) Summary page 4.

## Indications for use
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.

Source page: https://510kreport.com/device/K212548
Methodology: https://510kreport.com/methodology