Amber® Mill Direct
Amber Mill Direct is a fully crystallized lithium disilicate block used to mill dental restorations. Computer-aided design and manufacturing equipment shapes the block into inlays, onlays,…
Amber Mill Direct is a fully crystallized lithium disilicate block used to mill dental restorations. Computer-aided design and manufacturing equipment shapes the block into inlays, onlays, veneers, partial crowns or crowns. The material does not require a crystallization firing after milling.
Its glass ceramic contains silica and lithium oxide with other oxides and inorganic pigments. Shade and translucency options allow selection of a block for the restoration being made.
Block Format
The C12 format measures 10 by 12 by 15 mm. Amber Mill Direct is the solid restoration block; the separately described Amber Mill Direct Q format has a central opening for a zirconia cap used in an abutment restoration.
33manufacturers in China registered for this device type
267catalogue 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.
| 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
| 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) | K202952 |
| Record published | 2024-05-06 |
| Record revised | 2025-05-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Amber Mill Direct HT C16/C2 | 5 | In distribution | |
| Amber Mill Direct LT C12/D4 | 5 | In distribution | |
| Amber Mill Direct HT C14/C1 | 5 | In distribution | |
| Amber Mill Direct HT C14/B1 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/D4 | 5 | In distribution | |
| Amber Mill Direct LT C14/C4 | 5 | In distribution | |
| Amber Mill Direct HT C12/D4 | 5 | In distribution | |
| Amber Mill Direct LT C12/B4 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/B2 | 5 | In distribution | |
| Amber Mill Direct LT C16/D4 | 5 | In distribution | |
| Amber Mill Direct MT C14/A4 | 5 | In distribution | |
| Amber Mill Direct HT C16/B4 | 5 | In distribution | |
| Amber Mill Direct MT C12/C3 | 5 | In distribution | |
| Amber Mill Direct MT C14/W1 | 5 | In distribution | |
| Amber Mill Direct MT C16/W3 | 5 | In distribution | |
| Amber Mill Direct LT C16/W2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/C1 | 5 | In distribution | |
| Amber Mill Direct HT C16/C4 | 5 | In distribution | |
| Amber Mill Direct HT C12/C4 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/D2 | 5 | In distribution | |
| Amber Mill Direct LT C16/A4 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/C3 | 5 | In distribution | |
| Amber Mill Direct LT C12/W4 | 5 | In distribution | |
| Amber Mill Direct MT C14/W4 | 5 | In distribution | |
| Amber Mill Direct LT C16/B1 | 5 | In distribution | |
| Amber Mill Direct MT C14/W3 | 5 | In distribution | |
| Amber Mill Direct MT C12/A3.5 | 5 | In distribution | |
| Amber Mill Direct MT C12/B3 | 5 | In distribution | |
| Amber Mill Direct HT C12/W2 | 5 | In distribution | |
| Amber Mill Direct HT C16/D3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/B2 | 5 | In distribution | |
| Amber Mill Direct LT C12/C4 | 5 | In distribution | |
| Amber Mill Direct HT C14/W4 | 5 | In distribution | |
| Amber Mill Direct LT C14/C3 | 5 | In distribution | |
| Amber Mill Direct LT C16/B4 | 5 | In distribution | |
| Amber Mill Direct MT C16/D4 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/D3 | 5 | In distribution | |
| Amber Mill Direct MO C14/0 | 5 | In distribution | |
| Amber Mill Direct MT C16/C2 | 5 | In distribution | |
| Amber Mill Direct LT C12/A4 | 5 | In distribution | |
| Amber Mill Direct MT C14/C2 | 5 | In distribution | |
| Amber Mill Direct HT C16/B2 | 5 | In distribution | |
| Amber Mill Direct MT C16/B4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/W4 | 5 | In distribution | |
| Amber Mill Direct LT C16/C2 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/B2 | 5 | In distribution | |
| Amber Mill Direct HT C16/A3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/C4 | 5 | In distribution | |
| Amber Mill Direct LT C16/C3 | 5 | In distribution | |
| Amber Mill Direct LT C16/A2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/W0 | 5 | In distribution | |
| Amber Mill Direct HT C16/W2 | 5 | In distribution | |
| Amber Mill Direct MO C16/3 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/B1 | 5 | In distribution | |
| Amber Mill Direct MT C16/D3 | 5 | In distribution | |
| Amber Mill Direct MT C12/B4 | 5 | In distribution | |
| Amber Mill Direct LT C14/C1 | 5 | In distribution | |
| Amber Mill Direct MO C12/3 | 5 | In distribution | |
| Amber Mill Direct MT C12/W3 | 5 | In distribution | |
| Amber Mill Direct HT C16/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/A3 | 5 | In distribution | |
| Amber Mill Direct MT C12/B2 | 5 | In distribution | |
| Amber Mill Direct HT C12/W4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/D2 | 5 | In distribution | |
| Amber Mill Direct MT C14/D3 | 5 | In distribution | |
| Amber Mill Direct LT C14/D2 | 5 | In distribution | |
| Amber Mill Direct MT C14/C3 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/C3 | 5 | In distribution | |
| Amber Mill Direct MT C12/W4 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT C12/A2 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/C2 | 5 | In distribution | |
| Amber Mill Direct LT C12/D3 | 5 | In distribution | |
| Amber Mill Direct HT C16/W3 | 5 | In distribution | |
| Amber Mill Direct HT C14/W2 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/A2 | 5 | In distribution | |
| Amber Mill Direct HT C14/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT C14/D3 | 5 | In distribution | |
| Amber Mill Direct MO C12/2 | 5 | In distribution | |
| Amber Mill Direct MT C12/C1 | 5 | In distribution | |
| Amber Mill Direct LT C14/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/D3 | 5 | In distribution | |
| Amber Mill Direct LT C16/W3 | 5 | In distribution | |
| Amber Mill Direct LT C12/W0 | 5 | In distribution | |
| Amber Mill Direct MO C16/4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/D3 | 5 | In distribution | |
| Amber Mill Direct MT C16/A3 | 5 | In distribution | |
| Amber Mill Direct MT C16/C3 | 5 | In distribution | |
| Amber Mill Direct HT C12/W3 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/A4 | 5 | In distribution | |
| Amber Mill Direct HT C14/B4 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/C4 | 5 | In distribution | |
| Amber Mill Direct HT C14/W3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/B4 | 5 | In distribution | |
| Amber Mill Direct MO C12/4 | 5 | In distribution | |
| Amber Mill Direct HT C12/A3.5 | 5 | In distribution | |
| Amber Mill Direct MT C16/C1 | 5 | In distribution | |
| Amber Mill Direct MO C14/3 | 5 | In distribution | |
| Amber Mill Direct HT C14/C4 | 5 | In distribution | |
| Amber Mill Direct LT C12/B1 | 5 | In distribution | |
| Amber Mill Direct MT C12/D2 | 5 | In distribution | |
| Amber Mill Direct LT C12/D2 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/C1 | 5 | In distribution | |
| Amber Mill Direct MO C16/2 | 5 | In distribution | |
| Amber Mill Direct HT C12/A1 | 5 | In distribution | |
| Amber Mill Direct MO C16/0 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/W3 | 5 | In distribution | |
| Amber Mill Direct HT C12/W0 | 5 | In distribution | |
| Amber Mill Direct MT C16/D2 | 5 | In distribution | |
| Amber Mill Direct HT C16/B1 | 5 | In distribution | |
| Amber Mill Direct HT C16/D4 | 5 | In distribution | |
| Amber Mill Direct MT C16/C4 | 5 | In distribution | |
| Amber Mill Direct MT C14/W2 | 5 | In distribution | |
| Amber Mill Direct LT C14/A4 | 5 | In distribution | |
| Amber Mill Direct MT C14/B3 | 5 | In distribution | |
| Amber Mill Direct MT C16/B2 | 5 | In distribution | |
| Amber Mill Direct HT C14/A3 | 5 | In distribution | |
| Amber Mill Direct HT C12/C2 | 5 | In distribution | |
| Amber Mill Direct LT C12/A2 | 5 | In distribution | |
| Amber Mill Direct LT C14/W4 | 5 | In distribution | |
| Amber Mill Direct HT C12/B1 | 5 | In distribution | |
| Amber Mill Direct MT C12/C2 | 5 | In distribution | |
| Amber Mill Direct MO C12/1 | 5 | In distribution | |
| Amber Mill Direct HT C14/C3 | 5 | In distribution | |
| Amber Mill Direct HT C12/B4 | 5 | In distribution | |
| Amber Mill Direct LT C14/C2 | 5 | In distribution | |
| Amber Mill Direct HT C14/A2 | 5 | In distribution | |
| Amber Mill Direct MT C14/W0 | 5 | In distribution | |
| Amber Mill Direct HT C12/C1 | 5 | In distribution | |
| Amber Mill Direct LT C16/W1 | 5 | In distribution | |
| Amber Mill Direct MT C16/B3 | 5 | In distribution | |
| Amber Mill Direct HT C14/D2 | 5 | In distribution | |
| Amber Mill Direct MO C16/1 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/C2 | 5 | In distribution | |
| Amber Mill Direct LT C12/A3.5 | 5 | In distribution | |
| Amber Mill Direct MT C14/A2 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/W1 | 5 | In distribution | |
| Amber Mill Direct LT C14/A3 | 5 | In distribution | |
| Amber Mill Direct LT C16/C1 | 5 | In distribution | |
| Amber Mill Direct MT C12/A2 | 5 | In distribution | |
| Amber Mill Direct HT C12/C3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/B1 | 5 | In distribution | |
| Amber Mill Direct LT C16/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/B4 | 5 | In distribution | |
| Amber Mill Direct LT C12/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/W3 | 5 | In distribution | |
| Amber Mill Direct LT C16/W0 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/D2 | 5 | In distribution | |
| Amber Mill Direct LT C14/W0 | 5 | In distribution | |
| Amber Mill Direct MT C16/A2 | 5 | In distribution | |
| Amber Mill Direct MT C12/W1 | 5 | In distribution | |
| Amber Mill Direct MT C14/B1 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/A1 | 5 | In distribution | |
| Amber Mill Direct HT C16/B3 | 5 | In distribution | |
| Amber Mill Direct LT C12/B3 | 5 | In distribution | |
| Amber Mill Direct HT C16/A4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/W2 | 5 | In distribution | |
| Amber Mill Direct MT C14/A3.5 | 5 | In distribution | |
| Amber Mill Direct LT C16/D3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/C2 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/A4 | 5 | In distribution | |
| Amber Mill Direct LT C14/D4 | 5 | In distribution | |
| Amber Mill Direct MT C14/B4 | 5 | In distribution | |
| Amber Mill Direct MT C14/C4 | 5 | In distribution | |
| Amber Mill Direct HT C16/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT C14/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/A3 | 5 | In distribution | |
| Amber Mill Direct MT C16/B1 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/W2 | 5 | In distribution | |
| Amber Mill Direct LT C12/A3 | 5 | In distribution | |
| Amber Mill Direct HT C12/D2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/B3 | 5 | In distribution | |
| Amber Mill Direct LT C12/C3 | 5 | In distribution | |
| Amber Mill Direct LT C14/B1 | 5 | In distribution | |
| Amber Mill Direct HT C16/C1 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/W0 | 5 | In distribution | |
| Amber Mill Direct MT C16/W2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/A3 | 5 | In distribution | |
| Amber Mill Direct MT C14/A3 | 5 | In distribution | |
| Amber Mill Direct HT C16/D2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/A2 | 5 | In distribution | |
| Amber Mill Direct MT C12/A1 | 5 | In distribution | |
| Amber Mill Direct LT C14/W2 | 5 | In distribution | |
| Amber Mill Direct LT C12/C2 | 5 | In distribution | |
| Amber Mill Direct HT C14/D4 | 5 | In distribution | |
| Amber Mill Direct MT C14/A1 | 5 | In distribution | |
| Amber Mill Direct MT C16/A3.5 | 5 | In distribution | |
| Amber Mill Direct MT C12/A3 | 5 | In distribution | |
| Amber Mill Direct LT C12/B2 | 5 | In distribution | |
| Amber Mill Direct HT C14/C2 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/D4 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/W4 | 5 | In distribution | |
| Amber Mill Direct MO C12/0 | 5 | In distribution | |
| Amber Mill Direct MT C12/B1 | 5 | In distribution | |
| Amber Mill Direct LT C12/W2 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/D4 | 5 | In distribution | |
| Amber Mill Direct MT C16/W1 | 5 | In distribution | |
| Amber Mill Direct LT C16/W4 | 5 | In distribution | |
| Amber Mill Direct MT C12/A4 | 5 | In distribution | |
| Amber Mill Direct MT C16/A4 | 5 | In distribution | |
| Amber Mill Direct HT C12/A4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/C1 | 5 | In distribution | |
| Amber Mill Direct MT C16/W4 | 5 | In distribution | |
| Amber Mill Direct LT C14/D3 | 5 | In distribution | |
| Amber Mill Direct MT C16/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/B3 | 5 | In distribution | |
| Amber Mill Direct MT C12/W0 | 5 | In distribution | |
| Amber Mill Direct LT C14/W3 | 5 | In distribution | |
| Amber Mill Direct LT C12/W1 | 5 | In distribution | |
| Amber Mill Direct HT C14/W1 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/A2 | 5 | In distribution | |
| Amber Mill Direct HT C12/D3 | 5 | In distribution | |
| Amber Mill Direct MO C14/2 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/W0 | 5 | In distribution | |
| Amber Mill Direct LT C16/A1 | 5 | In distribution | |
| Amber Mill Direct HT C12/A3 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/W4 | 5 | In distribution | |
| Amber Mill Direct HT+ C14/C4 | 5 | In distribution | |
| Amber Mill Direct MT C14/D2 | 5 | In distribution | |
| Amber Mill Direct HT C16/C3 | 5 | In distribution | |
| Amber Mill Direct MT C14/B2 | 5 | In distribution | |
| Amber Mill Direct LT C14/A3.5 | 5 | In distribution | |
| Amber Mill Direct HT C16/A2 | 5 | In distribution | |
| Amber Mill Direct LT C16/A3 | 5 | In distribution | |
| Amber Mill Direct HT C12/W1 | 5 | In distribution | |
| Amber Mill Direct LT C16/C4 | 5 | In distribution | |
| Amber Mill Direct LT C14/B3 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/W3 | 5 | In distribution | |
| Amber Mill Direct HT C16/W4 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/B4 | 5 | In distribution | |
| Amber Mill Direct MT C12/D3 | 5 | In distribution | |
| Amber Mill Direct LT C16/B3 | 5 | In distribution | |
| Amber Mill Direct LT C14/W1 | 5 | In distribution | |
| Amber Mill Direct HT C14/W0 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/B3 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/W2 | 5 | In distribution | |
| Amber Mill Direct LT C14/A2 | 5 | In distribution | |
| Amber Mill Direct HT C16/W1 | 5 | In distribution | |
| Amber Mill Direct HT C12/B2 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/W1 | 5 | In distribution | |
| Amber Mill Direct MT C12/W2 | 5 | In distribution | |
| Amber Mill Direct HT+ C12/A1 | 5 | In distribution | |
| Amber Mill Direct HT+ C16/B1 | 5 | In distribution | |
| Amber Mill Direct LT C12/W3 | 5 | In distribution | |
| Amber Mill Direct MT C14/D4 | 5 | In distribution | |
| Amber Mill Direct LT C14/B4 | 5 | In distribution | |
| Amber Mill Direct HT C16/W0 | 5 | In distribution | |
| Amber Mill Direct LT C16/B2 | 5 | In distribution |
Showing 250 of 267 catalogue numbers.
Same 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
| 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.