Dental Porcelain Powder

Dental Porcelain Powder is a veneering material for fixed crowns and bridges. The product range combines porcelain powder, stain or glaze and blending liquid for preparation by trained…

Registry build 21.09.26

Dental Porcelain Powder is a veneering material for fixed crowns and bridges. The product range combines porcelain powder, stain or glaze and blending liquid for preparation by trained dental laboratory professionals.

The powder contains silica, alumina and other metal oxides. Its blending liquid contains purified water, 1,3-butanediol and diethanolamine, while the stain or glaze combines powder and liquid in a 1:1 mass ratio.

Laboratory Preparation

The powder is mixed with blending liquid to form a paste for layering. Mixing should leave no pigment separation or clumps, and the compacted layers should dry without cracking or wrinkling.

33manufacturers in China registered for this device type
13catalogue 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 Dental Porcelain Powder
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) K232676
Record published 2025-07-22
Record revised 2025-09-15 (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 Dental Porcelain Powder
Catalogue number Size Status
Porcelain Powder TD B1 20g In distribution
Porcelain Powder TD A1 20g In distribution
Porcelain Powder TD A2 20g In distribution
Blending liquid H 20ml In distribution
Stain/Glaze BS C5 20g In distribution
Porcelain Powder WIN 20g In distribution
Blending liquid H 10ml In distribution
Stain/Glaze BS C5 6g In distribution
Porcelain Powder EN L 20g In distribution
Porcelain Powder TD 3M2 20g In distribution
Porcelain Powder NT 20g In distribution
Porcelain Powder TD 2M2 20g In distribution
Porcelain Powder TD A3 20g 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

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