Amber® Mill

Amber Mill is a lithium-silicate glass ceramic supplied as blocks for making dental restorations with CAD/CAM equipment. Milling removes material from a selected block to form a restoration…

Registry build 21.09.26

Amber Mill is a lithium-silicate glass ceramic supplied as blocks for making dental restorations with CAD/CAM equipment. Milling removes material from a selected block to form a restoration such as a crown, veneer, inlay or onlay.

The glass ceramic contains silica, lithium oxide and other oxides, with inorganic pigments for different shades. The range includes different block sizes and shapes to accommodate milling equipment and the planned restoration.

Restoration and Appearance Options

The range supports anterior and posterior single crowns and anterior three-unit bridges, as well as veneers, inlays and onlays. Shade and translucency choices affect appearance, while Amber Press ingots use a separate hot-press fabrication method.

33manufacturers in China registered for this device type
504catalogue numbers in this listing
5510(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 Amber® Mill
Listed by Hass Corp., South Korea
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Manufacturer
510(k) K160102
Record published 2024-05-01

Specifications

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

Catalogue Numbers

Catalogue numbers for Amber® Mill
Catalogue number Size Per pack Status
Amber MIll P9806/B3 In distribution
Amber MIll P9818/A3.5 In distribution
Amber MIll H9816/A3.5 In distribution
Amber MIll H9814/D2 In distribution
Amber MIll C40/D2 3 In distribution
Amber MIll Z9520/C3 In distribution
Amber MIll C40/C3 3 In distribution
Amber MIll P9816/W4 In distribution
Amber MIll P9806/A1 In distribution
Amber MIll P9810/W2 In distribution
Amber MIll H9808/D2 In distribution
Amber MIll Z9516/B2 In distribution
Amber MIll Z9512/D4 In distribution
Amber MIll Z9518/A3.5 In distribution
Amber MIll P9820/W0 In distribution
Amber MIll P9812/D2 In distribution
Amber MIll Z9512/W1 In distribution
Amber MIll P9808/A1 In distribution
Amber MIll H9808/B3 In distribution
Amber MIll H9814/B3 In distribution
Amber MIll H9816/B4 In distribution
Amber MIll Z9518/W3 In distribution
Amber MIll Z9516/B4 In distribution
Amber MIll H9812/C2 In distribution
Amber MIll C14/W0 5 In distribution
Amber MIll Z9512/W0 In distribution
Amber MIll C14/A2 5 In distribution
Amber MIll P9808/D4 In distribution
Amber MIll P9806/C2 In distribution
Amber MIll C32/B2 3 In distribution
Amber MIll Z9518/D2 In distribution
Amber MIll P9808/A3 In distribution
Amber MIll P9816/W2 In distribution
Amber MIll H9814/A4 In distribution
Amber MIll C40/A3.5 3 In distribution
Amber MIll C16/D3 5 In distribution
Amber MIll Z9520/A4 In distribution
Amber MIll C16/D4 5 In distribution
Amber MIll Z9510/A3.5 In distribution
Amber MIll Z9518/D4 In distribution
Amber MIll H9816/W0 In distribution
Amber MIll C12/A1 5 In distribution
Amber MIll Z9510/W0 In distribution
Amber MIll C40/B2 3 In distribution
Amber MIll Z9514/B3 In distribution
Amber MIll Z9520/W0 In distribution
Amber MIll H9816/C4 In distribution
Amber MIll P9808/A2 In distribution
Amber MIll Z9520/A1 In distribution
Amber MIll P9818/B1 In distribution
Amber MIll Z9520/C2 In distribution
Amber MIll P9820/B2 In distribution
Amber MIll C40/A1 3 In distribution
Amber MIll Z9516/W0 In distribution
Amber MIll C32/C2 3 In distribution
Amber MIll H9808/A4 In distribution
Amber MIll P9806/B4 In distribution
Amber MIll H9810/W3 In distribution
Amber MIll Z9518/A1 In distribution
Amber MIll C14/C3 5 In distribution
Amber MIll P9812/W2 In distribution
Amber MIll H9810/W4 In distribution
Amber MIll P9814/B3 In distribution
Amber MIll C40/A4 3 In distribution
Amber MIll Z9512/W4 In distribution
Amber MIll H9810/A1 In distribution
Amber MIll Z9512/A4 In distribution
Amber MIll H9816/D4 In distribution
Amber MIll Z9514/W2 In distribution
Amber MIll P9812/W1 In distribution
Amber MIll H9814/B2 In distribution
Amber MIll P9808/W1 In distribution
Amber MIll C12/B1 5 In distribution
Amber MIll P9816/B3 In distribution
Amber MIll C32/B4 3 In distribution
Amber MIll P9814/W4 In distribution
Amber MIll P9808/A4 In distribution
Amber MIll Z9520/W1 In distribution
Amber MIll P9810/D2 In distribution
Amber MIll P9820/C3 In distribution
Amber MIll Z9518/B1 In distribution
Amber MIll P9814/C2 In distribution
Amber MIll Z9518/A2 In distribution
Amber MIll H9816/C1 In distribution
Amber MIll C12/A3.5 5 In distribution
Amber MIll Z9514/A3 In distribution
Amber MIll P9820/A1 In distribution
Amber MIll P9814/A2 In distribution
Amber MIll C16/W4 5 In distribution
Amber MIll C40/W4 3 In distribution
Amber MIll P9814/D2 In distribution
Amber MIll Z9510/B2 In distribution
Amber MIll C40/W2 3 In distribution
Amber MIll C12/B4 5 In distribution
Amber MIll H9814/C2 In distribution
Amber MIll P9812/D3 In distribution
Amber MIll P9818/W1 In distribution
Amber MIll P9806/A2 In distribution
Amber MIll C32/W3 3 In distribution
Amber MIll P9812/C4 In distribution
Amber MIll H9810/A4 In distribution
Amber MIll Z9514/C2 In distribution
Amber MIll H9814/A3.5 In distribution
Amber MIll C16/B4 5 In distribution
Amber MIll H9812/D4 In distribution
Amber MIll C12/B2 5 In distribution
Amber MIll P9814/A3 In distribution
Amber MIll C40/B4 3 In distribution
Amber MIll C14/B1 5 In distribution
Amber MIll C14/C2 5 In distribution
Amber MIll H9808/W1 In distribution
Amber MIll P9814/C4 In distribution
Amber MIll P9818/C2 In distribution
Amber MIll C14/A4 5 In distribution
Amber MIll H9812/B3 In distribution
Amber MIll C12/D2 5 In distribution
Amber MIll C32/A1 3 In distribution
Amber MIll C12/C3 5 In distribution
Amber MIll H9812/B4 In distribution
Amber MIll P9808/A3.5 In distribution
Amber MIll Z9514/A1 In distribution
Amber MIll H9812/A3 In distribution
Amber MIll P9810/B1 In distribution
Amber MIll Z9510/W3 In distribution
Amber MIll P9814/W3 In distribution
Amber MIll Z9510/C3 In distribution
Amber MIll H9808/C3 In distribution
Amber MIll Z9520/W3 In distribution
Amber MIll C40/C4 3 In distribution
Amber MIll P9818/B3 In distribution
Amber MIll Z9514/W1 In distribution
Amber MIll H9810/B1 In distribution
Amber MIll C16/C3 5 In distribution
Amber MIll H9812/C1 In distribution
Amber MIll H9810/C2 In distribution
Amber MIll Z9516/W3 In distribution
Amber MIll C12/C4 5 In distribution
Amber MIll H9810/W2 In distribution
Amber MIll Z9510/D2 In distribution
Amber MIll Z9516/D3 In distribution
Amber MIll P9810/A3.5 In distribution
Amber MIll C32/D4 3 In distribution
Amber MIll H9816/A4 In distribution
Amber MIll C32/C4 3 In distribution
Amber MIll Z9512/W2 In distribution
Amber MIll P9820/W3 In distribution
Amber MIll Z9518/C4 In distribution
Amber MIll P9818/D4 In distribution
Amber MIll H9814/C3 In distribution
Amber MIll H9816/W1 In distribution
Amber MIll H9808/W0 In distribution
Amber MIll C12/C1 5 In distribution
Amber MIll P9808/B2 In distribution
Amber MIll H9810/B4 In distribution
Amber MIll H9810/D4 In distribution
Amber MIll H9816/A3 In distribution
Amber MIll H9808/D3 In distribution
Amber MIll H9816/D3 In distribution
Amber MIll C40/D3 3 In distribution
Amber MIll Z9520/D4 In distribution
Amber MIll H9812/W1 In distribution
Amber MIll P9810/D3 In distribution
Amber MIll Z9514/C4 In distribution
Amber MIll C16/C1 5 In distribution
Amber MIll P9820/A4 In distribution
Amber MIll Z9512/B4 In distribution
Amber MIll C12/B3 5 In distribution
Amber MIll H9814/C1 In distribution
Amber MIll C16/D2 5 In distribution
Amber MIll Z9514/A3.5 In distribution
Amber MIll C16/A2 5 In distribution
Amber MIll P9806/D4 In distribution
Amber MIll C16/A1 5 In distribution
Amber MIll H9814/A1 In distribution
Amber MIll P9814/W0 In distribution
Amber MIll Z9516/C1 In distribution
Amber MIll P9816/D3 In distribution
Amber MIll Z9518/W4 In distribution
Amber MIll H9812/A4 In distribution
Amber MIll P9806/C1 In distribution
Amber MIll Z9518/B4 In distribution
Amber MIll P9820/D2 In distribution
Amber MIll Z9510/A2 In distribution
Amber MIll P9808/D3 In distribution
Amber MIll H9814/W2 In distribution
Amber MIll C12/W4 5 In distribution
Amber MIll Z9518/D3 In distribution
Amber MIll H9808/A3.5 In distribution
Amber MIll P9812/B1 In distribution
Amber MIll C16/B2 5 In distribution
Amber MIll P9820/W2 In distribution
Amber MIll P9818/W0 In distribution
Amber MIll P9812/D4 In distribution
Amber MIll Z9514/B2 In distribution
Amber MIll H9810/C3 In distribution
Amber MIll P9810/A4 In distribution
Amber MIll H9814/D4 In distribution
Amber MIll H9814/W0 In distribution
Amber MIll C12/D3 5 In distribution
Amber MIll P9820/A3 In distribution
Amber MIll H9812/W4 In distribution
Amber MIll P9820/B4 In distribution
Amber MIll P9810/W0 In distribution
Amber MIll P9808/C4 In distribution
Amber MIll P9806/W0 In distribution
Amber MIll P9808/W0 In distribution
Amber MIll P9806/B1 In distribution
Amber MIll P9818/D3 In distribution
Amber MIll C12/A2 5 In distribution
Amber MIll H9816/B3 In distribution
Amber MIll P9808/W3 In distribution
Amber MIll Z9518/C2 In distribution
Amber MIll H9812/C4 In distribution
Amber MIll C16/W1 5 In distribution
Amber MIll P9806/W1 In distribution
Amber MIll P9818/A4 In distribution
Amber MIll H9808/W2 In distribution
Amber MIll C32/A2 3 In distribution
Amber MIll P9820/C1 In distribution
Amber MIll C32/A4 3 In distribution
Amber MIll P9814/B1 In distribution
Amber MIll C32/C1 3 In distribution
Amber MIll P9812/A3 In distribution
Amber MIll C40/A3 3 In distribution
Amber MIll P9820/B3 In distribution
Amber MIll Z9514/B4 In distribution
Amber MIll P9812/B2 In distribution
Amber MIll P9810/W4 In distribution
Amber MIll C32/D3 3 In distribution
Amber MIll P9812/B4 In distribution
Amber MIll H9816/B1 In distribution
Amber MIll C16/B3 5 In distribution
Amber MIll P9820/A3.5 In distribution
Amber MIll P9812/A1 In distribution
Amber MIll H9814/W4 In distribution
Amber MIll P9812/C1 In distribution
Amber MIll Z9520/B3 In distribution
Amber MIll C40/B3 3 In distribution
Amber MIll P9814/C3 In distribution
Amber MIll H9808/A2 In distribution
Amber MIll P9806/A3 In distribution
Amber MIll P9814/W1 In distribution
Amber MIll H9808/A3 In distribution
Amber MIll P9808/W4 In distribution
Amber MIll C12/W0 5 In distribution
Amber MIll Z9512/W3 In distribution
Amber MIll Z9510/W2 In distribution
Amber MIll Z9514/W3 In distribution
Amber MIll H9814/A2 In distribution
Amber MIll P9820/B1 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
K260859 2026-06-11
K202952 2021-08-26
K160102 2016-07-14
K111573 2011-08-26
K102305 2010-12-03

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