Luxen CL

Luxen CL is a water-based coloring liquid with inorganic pigments for dental zirconia. Dental technicians brush it onto zirconia ceramic or immerse the ceramic before final sintering,…

Registry build 21.09.26

Luxen CL is a water-based coloring liquid with inorganic pigments for dental zirconia. Dental technicians brush it onto zirconia ceramic or immerse the ceramic before final sintering, giving the milled restoration its intended coloration.

The liquid supports complete or partial coloring of zirconia frameworks and restorations. It acts during laboratory fabrication, before the finished dental prosthesis is placed.

Shades and Dilution

The range offers 100 shades in 10, 30, 50 and 100 mL volumes. Luxen CL-Diluent and Luxen CL-Pontic Liquid dilute the base and special-color liquids, allowing color application to be adjusted within the system. The coloring liquids are supplied nonsterile.

33manufacturers in China registered for this device type
438catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIH
Manufacturer City Province Registered as Device types
BMF Tech (Zhuhai) Inc. Zhuhai Guangdong Contract manufacturer 2
Jiangxi Rekonova Dental Materials Co., Ltd. Jiujiang Jiangxi Contract manufacturer 1
Aidite (Qinhuangdao) Technology Co., Ltd. Qinhuangdao Hebei Repacker / relabeller 17
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
Qinhuangdao Audental Metal Technology Co., Ltd. Qinhuangdao Hebei Manufacturer 11
Liaoning Upcera Co., Ltd. Benxi Liaoning Contract manufacturer 10
Shenzhen Upcera Digital Dental Technology Co., Ltd. Shenzhen Guangdong Exporter 10
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7
Shenzhen Yurucheng Dental Materials Co., Ltd. Shenzhen Guangdong Manufacturer 6
Hunan Vsmile Biotechnology Co., Ltd. Changsha Hunan Contract manufacturer 6
Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. Zhangzhou Henan Manufacturer 6

Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain

Record

Regulatory record for Luxen CL
Listed by Dentalmax Co., Ltd., South Korea
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Manufacturer
510(k) K212548
Record published 2022-03-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Luxen CL
Catalogue number Size Status
Luxen CL-0315 10ml In distribution
Luxen CL-CCV1 100ml In distribution
Luxen CL-3025 30ml In distribution
Luxen CL-B2D 30ml In distribution
Luxen CL-2025 30ml In distribution
Luxen CL-Gingiva 1 50ml In distribution
Luxen CL-Enamel 2 10ml In distribution
Luxen CL-DA3.5 100ml In distribution
Luxen CL-D3D 100ml In distribution
Luxen CL-43 100ml In distribution
Luxen CL-CCV3 100ml In distribution
Luxen CL-41 100ml In distribution
Luxen CL-White Opaque 10ml In distribution
Luxen CL-MD2 30ml In distribution
Luxen CL-Cervical A 100ml In distribution
Luxen CL-53 100ml In distribution
Luxen CL-0215 30ml In distribution
Luxen CL-4015 10ml In distribution
Luxen CL-Cervical A 50ml In distribution
Luxen CL-DA3 100ml In distribution
Luxen CL-A4D 30ml In distribution
Luxen CL-Enamel 2 30ml In distribution
Luxen CL-21 10ml In distribution
Luxen CL-4015 30ml In distribution
Luxen CL-DA3 30ml In distribution
Luxen CL-31 10ml In distribution
Luxen CL-33 30ml In distribution
Luxen CL-CCV1 30ml In distribution
Luxen CL-0425 30ml In distribution
Luxen CL-31 30ml In distribution
Luxen CL-B2D 50ml In distribution
Luxen CL-0225 50ml In distribution
Luxen CL-C4D 10ml In distribution
Luxen CL-White Enamel 30ml In distribution
Luxen CL-Enamel 2 100ml In distribution
Luxen CL-MB3 10ml In distribution
Luxen CL-DA4 50ml In distribution
Luxen CL-B4D 10ml In distribution
Luxen CL-B1D 10ml In distribution
Luxen CL-DD3 10ml In distribution
Luxen CL-C1D 10ml In distribution
Luxen CL-12 30ml In distribution
Luxen CL-DB3 100ml In distribution
Luxen CL-MB4 50ml In distribution
Luxen CL-Blue Opaque 30ml In distribution
Luxen CL-Natural Gray 1 10ml In distribution
Luxen CL-41 30ml In distribution
Luxen CL-Brown 50ml In distribution
Luxen CL-MB2 50ml In distribution
Luxen CL-DC4 100ml In distribution
Luxen CL-MC3 100ml In distribution
Luxen CL-DB2 10ml In distribution
Luxen CL-MC3 10ml In distribution
Luxen CL-02 30ml In distribution
Luxen CL-2015 50ml In distribution
Luxen CL-A1D 100ml In distribution
Luxen CL-12 50ml In distribution
Luxen CL-D2D 50ml In distribution
Luxen CL-Translucent 2 100ml In distribution
Luxen CL-22 100ml In distribution
Luxen CL-D2D 30ml In distribution
Luxen CL-Yellow 10ml In distribution
Luxen CL-B4D 100ml In distribution
Luxen CL-C3D 100ml In distribution
Luxen CL-Creamy White 10ml In distribution
Luxen CL-MB2 10ml In distribution
Luxen CL-23 10ml In distribution
Luxen CL-0325 50ml In distribution
Luxen CL-DC1 50ml In distribution
Luxen CL-DB4 50ml In distribution
Luxen CL-0425 50ml In distribution
Luxen CL-0425 100ml In distribution
Luxen CL-Enamel EP 50ml In distribution
Luxen CL-DA1 10ml In distribution
Luxen CL-Natural Gray 2 50ml In distribution
Luxen CL-0415 10ml In distribution
Luxen CL-Diluent 10ml In distribution
Luxen CL-4025 100ml In distribution
Luxen CL-32 30ml In distribution
Luxen CL-0415 50ml In distribution
Luxen CL-Enamel 1 50ml In distribution
Luxen CL-C2D 30ml In distribution
Luxen CL-DA2 30ml In distribution
Luxen CL-0325 30ml In distribution
Luxen CL-MB2 30ml In distribution
Luxen CL-White 100ml In distribution
Luxen CL-D3D 30ml In distribution
Luxen CL-4015 100ml In distribution
Luxen CL-Enamel 1 100ml In distribution
Luxen CL-MA3.5 10ml In distribution
Luxen CL-52 50ml In distribution
Luxen CL-42 100ml In distribution
Luxen CL-3025 100ml In distribution
Luxen CL-Cervical D 30ml In distribution
Luxen CL-C4D 100ml In distribution
Luxen CL-CCV2 30ml In distribution
Luxen CL-42 30ml In distribution
Luxen CL-DD4 100ml In distribution
Luxen CL-T-Glass 100ml In distribution
Luxen CL-DC2 30ml In distribution
Luxen CL-DC3 100ml In distribution
Luxen CL-33 50ml In distribution
Luxen CL-White Opaque 100ml In distribution
Luxen CL-Diluent 100ml In distribution
Luxen CL-MC4 10ml In distribution
Luxen CL-03 30ml In distribution
Luxen CL-CCV4 30ml In distribution
Luxen CL-01 10ml In distribution
Luxen CL-MA1 50ml In distribution
Luxen CL-43 10ml In distribution
Luxen CL-MB4 10ml In distribution
Luxen CL-DD3 30ml In distribution
Luxen CL-DB3 30ml In distribution
Luxen CL-C1D 100ml In distribution
Luxen CL-MD3 10ml In distribution
Luxen CL-A2D 100ml In distribution
Trial KIT 2 In distribution
Luxen CL-A4D 50ml In distribution
Luxen CL-Natural Gray 1 100ml In distribution
Luxen CL-51 100ml In distribution
Luxen CL-A2D 50ml In distribution
Luxen CL-42 10ml In distribution
Luxen CL-MC2 30ml In distribution
Luxen CL-Enamel 3 50ml In distribution
Luxen CL-Enamel 2 50ml In distribution
Luxen CL-4025 50ml In distribution
Luxen CL-0315 30ml In distribution
Luxen CL-B4D 30ml In distribution
Luxen CL-C3D 30ml In distribution
Luxen CL-White Enamel 10ml In distribution
Luxen CL-MA3 100ml In distribution
Luxen CL-Cervical D 100ml In distribution
Luxen CL-B1D 100ml In distribution
Luxen CL-Translucent 1 50ml In distribution
Dipping KIT In distribution
Luxen CL-Violet Opaque 100ml In distribution
Luxen CL-Gingiva 1 10ml In distribution
Luxen CL-C1D 30ml In distribution
Luxen CL-White Enamel 100ml In distribution
Luxen CL-DA4 10ml In distribution
Luxen CL-02 50ml In distribution
Luxen CL-A4D 10ml In distribution
Luxen CL-Natural Gray 1 30ml In distribution
Luxen CL-33 100ml In distribution
Luxen CL-B3D 30ml In distribution
Luxen CL-4025 10ml In distribution
Luxen CL-MA4 50ml In distribution
Luxen CL-0215 10ml In distribution
Luxen CL-Cervical D 10ml In distribution
Luxen CL-MA4 30ml In distribution
Luxen CL-D4D 50ml In distribution
Luxen CL-31 50ml In distribution
Luxen CL-43 50ml In distribution
Luxen CL-Natural Gray 2 10ml In distribution
Luxen CL-Gingiva 1 30ml In distribution
Luxen CL-52 30ml In distribution
Luxen CL-Translucent 2 30ml In distribution
Luxen CL-MC1 100ml In distribution
Luxen CL-CCV1 50ml In distribution
Luxen CL-Enamel EP 10ml In distribution
Luxen CL-CCV4 50ml In distribution
Luxen CL-DA2 50ml In distribution
Luxen CL-MA1 100ml In distribution
Luxen CL-Enamel 1 30ml In distribution
Luxen CL-0315 100ml In distribution
Luxen CL-Translucent 2 10ml In distribution
Luxen CL-DD4 30ml In distribution
Luxen CL-Deep Amber 10ml In distribution
Luxen CL-A2D 10ml In distribution
Luxen CL-Translucent 1 30ml In distribution
Luxen CL-Translucent 1 10ml In distribution
Luxen CL-Enamel EP 100ml In distribution
Luxen CL-3025 50ml In distribution
Luxen CL-B4D 50ml In distribution
Luxen CL-DB1 10ml In distribution
Luxen CL-Blue Opaque 50ml In distribution
Luxen CL-Natural Gray 1 50ml In distribution
Luxen CL-DB3 10ml In distribution
Luxen CL-Pontic Liquid 50ml In distribution
Luxen CL-0215 50ml In distribution
Luxen CL-DA3.5 10ml In distribution
Luxen CL-03 100ml In distribution
Luxen CL-B2D 100ml In distribution
Luxen CL-DC2 50ml In distribution
Luxen CL-2025 100ml In distribution
Luxen CL-DC4 50ml In distribution
Luxen CL-D4D 100ml In distribution
Luxen CL-MC4 100ml In distribution
Luxen CL-CCV3 30ml In distribution
Luxen CL-DC1 10ml In distribution
Luxen CL-Amber 30ml In distribution
Luxen CL-C4D 30ml In distribution
Luxen CL-MA4 100ml In distribution
Luxen CL-MA2 10ml In distribution
Luxen CL-DA1 30ml In distribution
Luxen CL-33 10ml In distribution
Luxen CL-MA3.5 30ml In distribution
Luxen CL-52 100ml In distribution
Luxen CL-Gingiva 1 100ml In distribution
Luxen CL-DB2 30ml In distribution
Luxen CL-42 50ml In distribution
Luxen CL-B2D 10ml In distribution
Luxen CL-MC3 50ml In distribution
Luxen CL-Cervical B 100ml In distribution
Luxen CL-MC1 30ml In distribution
Luxen CL-MB1 30ml In distribution
Luxen CL-DC1 30ml In distribution
Luxen CL-22 50ml In distribution
Luxen CL-Pontic Liquid 10ml In distribution
Luxen CL-Yellow 100ml In distribution
Luxen CL-DA2 10ml In distribution
Luxen CL-MA3 30ml In distribution
Luxen CL-A3D 10ml In distribution
Luxen CL-Enamel 3 30ml In distribution
Luxen CL-MA2 50ml In distribution
Luxen CL-Gingiva 2 100ml In distribution
Luxen CL-32 50ml In distribution
Luxen CL-01 30ml In distribution
Luxen CL-52 10ml In distribution
Luxen CL-C2D 10ml In distribution
Luxen CL-A3D 30ml In distribution
Luxen CL-MD2 10ml In distribution
Luxen CL-CCV2 100ml In distribution
Luxen CL-53 50ml In distribution
Luxen CL-MD4 100ml In distribution
Luxen CL-MD3 30ml In distribution
Luxen CL-Ice Blue 100ml In distribution
Luxen CL-C4D 50ml In distribution
Luxen CL-DA1 50ml In distribution
Luxen CL-DC4 30ml In distribution
Luxen CL-Deep Amber 100ml In distribution
Luxen CL-DA3 10ml In distribution
Luxen CL-41 10ml In distribution
Luxen CL-White 10ml In distribution
Luxen CL-DD3 50ml In distribution
Luxen CL-White 30ml In distribution
Luxen CL-White Opaque 50ml In distribution
Luxen CL-Violet Opaque 10ml In distribution
Luxen CL-DB2 50ml In distribution
Luxen CL-0225 30ml In distribution
Luxen CL-DC3 50ml In distribution
Luxen CL-A1D 10ml In distribution
Luxen CL-0225 10ml In distribution
Luxen CL-MA3 10ml In distribution
Luxen CL-MA1 10ml In distribution
Luxen CL-Yellow 50ml In distribution
Luxen CL-3025 10ml In distribution
Luxen CL-A3.5D 100ml In distribution
Luxen CL-D3D 50ml In distribution
Luxen CL-DA3.5 30ml In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bloomden Bloomden Bioceramics (Hunan) Co., Ltd. 6,340
Upcera Dental Zirconia Blank For Aesthetic Restoration Liaoning Upcera Co., Ltd. 4,367
Aidite Aidite (Qinhuangdao) Technology Co., Ltd. 4,310
Luxen 5G Dentalmax Co., Ltd. 3,903
GC Initial™ GC America Inc. 2,724
Gradual Dental Zirconia Blank Liaoning Upcera Co., Ltd. 2,035
Multi M Series Dmax Co., Ltd. 1,854
Zirconia Dental Ceramics Chengdu Besmile Medical Technology Co., Ltd. 1,828
Amber® Mill Q Hass Corp. 1,602
Upcera Dental Zirconia Pre-Shaded Blank Liaoning Upcera Co., Ltd. 1,498
BruxZir Prismatik Dentalcraft, Inc. 1,295
ceraMotion® Dentaurum GmbH & Co. KG 1,062

Showing 12 of 10,017. All products under Powder, Porcelain

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K241151 2024-09-30
K212548 2021-12-06
K171585 2018-10-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer