Dental Zirconia Blank

Dental Zirconia Blanks are starting materials for ceramic dental restorations such as crowns, bridges, veneers, inlays and onlays. Dental laboratories and dental professionals shape them…

Registry build 21.09.26

Dental Zirconia Blanks are starting materials for ceramic dental restorations such as crowns, bridges, veneers, inlays and onlays. Dental laboratories and dental professionals shape them using CAD/CAM or manual milling machines. The blanks are then processed into the finished restoration.

The blanks are made from zirconia powder containing zirconium, yttrium, hafnium and aluminum oxides. The powder is formed into blanks for further fabrication. Pre-shaded configurations contain small amounts of inorganic pigments that provide tooth-like color after sintering.

Processing and Supply

The subject range includes HT-plus, ST-C, SHT-C, SHT-ML and Pro-ML models. The blanks are supplied nonsterile and intended for single use. Milling is followed by sintering in the dental laboratory.

33manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance

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 Zirconia Blank
Listed by Hunan Ceramaster Material Technology Co., Ltd., China
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Manufacturer
510(k) K240772
Record published 2026-06-06

Specifications

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

Catalogue Numbers

Catalogue numbers for Dental Zirconia Blank
Catalogue number Size Status
SHT-C In distribution
UT-C In distribution
Pro-ML In distribution
HT-plus In distribution
SHT-ML In distribution
ST-C In distribution
UT-ML In distribution
ST-ML 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
K240772 2024-05-20

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