Pre-Sintered Zirconia Coloring Liquid

Besmile Pre-Sintered Zirconia Coloring Liquid is a dental laboratory material used to color the manufacturer’s zirconia ceramics before sintering. The liquid is applied to the ceramic so…

Registry build 21.09.26

Besmile Pre-Sintered Zirconia Coloring Liquid is a dental laboratory material used to color the manufacturer’s zirconia ceramics before sintering. The liquid is applied to the ceramic so that color becomes part of the subsequent restoration-fabrication process.

The water-based range includes standard shade sets and special colors. Its formulations contain coloring salts such as ferric, erbium or yttrium chlorides, together with water and other additives; composition varies across the formulations.

Laboratory Processing

The coloring process includes immersion of the zirconia followed by drying before further processing. The liquid is specified for Besmile’s own Zirconia Dental Ceramics, so that material pairing is part of the product’s defined use.

33manufacturers in China registered for this device type
130catalogue 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 Pre-Sintered Zirconia Coloring Liquid
Listed by Chengdu Besmile Medical Technology Co., Ltd., China
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Manufacturer, Exporter
510(k) K232682
Record published 2025-07-22
Record revised 2025-10-01 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Pre-Sintered Zirconia Coloring Liquid
Catalogue number Size Status
A1 50ml In distribution
A1 20ml In distribution
4R2.5 50ml In distribution
TO3 50ml In distribution
5M2 50ml In distribution
TO3 20ml In distribution
2R1.5 50ml In distribution
0M3 20ml In distribution
2L2.5 20ml In distribution
0M1 20ml In distribution
B1 20ml In distribution
3M2 50ml In distribution
TO2 50ml In distribution
A2 50ml In distribution
A4 50ml In distribution
2M3 20ml In distribution
2R2.5 50ml In distribution
A3.5 20ml In distribution
C1 50ml In distribution
0M2 20ml In distribution
5M2 20ml In distribution
3R1.5 50ml In distribution
1M1 50ml In distribution
1M2 50ml In distribution
3M3 20ml In distribution
TO1 20ml In distribution
P3 50ml In distribution
P2 20ml In distribution
2M2 20ml In distribution
C4 20ml In distribution
4L1.5 20ml In distribution
G3 20ml In distribution
2M2 50ml In distribution
2L2.5 50ml In distribution
3M2 20ml In distribution
4L2.5 50ml In distribution
3L1.5 50ml In distribution
3R2.5 20ml In distribution
0M1 50ml In distribution
P2 50ml In distribution
B3 50ml In distribution
3M3 50ml In distribution
C3 50ml In distribution
D2 50ml In distribution
D3 50ml In distribution
2R1.5 20ml In distribution
B4 50ml In distribution
O2 50ml In distribution
C2 20ml In distribution
A4 20ml In distribution
3M1 50ml In distribution
2M1 20ml In distribution
B3 20ml In distribution
4R1.5 50ml In distribution
O1 50ml In distribution
V2 50ml In distribution
O3 50ml In distribution
4M1 50ml In distribution
A2 20ml In distribution
4L2.5 20ml In distribution
O2 20ml In distribution
3L1.5 20ml In distribution
P3 20ml In distribution
0M2 50ml In distribution
2L1.5 20ml In distribution
A3.5 50ml In distribution
A3 50ml In distribution
4M3 20ml In distribution
D3 20ml In distribution
3L2.5 20ml In distribution
5M3 20ml In distribution
3R2.5 50ml In distribution
C2 50ml In distribution
O3 20ml In distribution
4R2.5 20ml In distribution
4L1.5 50ml In distribution
BL1 50ml In distribution
V3 20ml In distribution
G2 50ml In distribution
A3 20ml In distribution
P1 50ml In distribution
V3 50ml In distribution
D2 20ml In distribution
V1 50ml In distribution
C3 20ml In distribution
2M3 50ml In distribution
B2 20ml In distribution
2M1 50ml In distribution
V1 20ml In distribution
BL3 50ml In distribution
BL2 50ml In distribution
2L1.5 50ml In distribution
G1 20ml In distribution
P1 20ml In distribution
G2 20ml In distribution
C1 20ml In distribution
B2 50ml In distribution
BL3 20ml In distribution
4R1.5 20ml In distribution
4M2 50ml In distribution
5M3 50ml In distribution
TO4 20ml In distribution
TO2 20ml In distribution
5M1 20ml In distribution
V2 20ml In distribution
B1 50ml In distribution
D4 50ml In distribution
TO4 50ml In distribution
5M1 50ml In distribution
1M2 20ml In distribution
2R2.5 20ml In distribution
3M1 20ml In distribution
BL1 20ml In distribution
C4 50ml In distribution
G1 50ml In distribution
4M3 50ml In distribution
D4 20ml In distribution
4M2 20ml In distribution
4M1 20ml In distribution
TO1 50ml In distribution
1M1 20ml In distribution
O1 20ml In distribution
BL2 20ml In distribution
BL4 50ml In distribution
BL4 20ml In distribution
G3 50ml In distribution
B4 20ml In distribution
0M3 50ml In distribution
3L2.5 50ml In distribution
3R1.5 20ml In distribution

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
K232682 2024-03-19
K232676 2024-01-23
K232673 2024-01-23

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

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2,581device types they are registered for
340,248device records, each naming its maker
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