Amber® Press
Amber Press is a lithium-silicate glass ceramic supplied as ingots for dental restorations made by hot pressing. Its applications include anterior and posterior single crowns, veneers,…
Amber Press is a lithium-silicate glass ceramic supplied as ingots for dental restorations made by hot pressing. Its applications include anterior and posterior single crowns, veneers, inlays, onlays and anterior three-unit bridges.
The ceramic contains silica, lithium oxide and other oxides, with inorganic pigments providing different shades. Available translucency and opacity options allow selection to match the intended restoration.
Restoration Scope
The hot-press process distinguishes Amber Press from the related CAD/CAM-milled material. Anterior three-unit bridge use does not include molar restoration, and different blank shapes and shades accommodate tooth geometry and color.
33manufacturers in China registered for this device type
188catalogue 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) | K160102 |
| Record published | 2024-05-01 |
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 Press LT R10/A3 | 5 | In distribution | |
| Amber Press LT R20/A3 | 3 | In distribution | |
| Amber Press HT R20/D2 | 3 | In distribution | |
| Amber Press HT R10/C1 | 5 | In distribution | |
| Amber Press LT R15/A3 | 3 | In distribution | |
| Amber Press HT R7/W1 | 5 | In distribution | |
| Amber Press HT R10/B1 | 5 | In distribution | |
| Amber Press LT R7/A4 | 5 | In distribution | |
| Amber Press MO R20/2 | 3 | In distribution | |
| Amber Press MO R20/0 | 3 | In distribution | |
| Amber Press LT R10/W2 | 5 | In distribution | |
| Amber Press HT R10/C3 | 5 | In distribution | |
| Amber Press LT R15/B4 | 3 | In distribution | |
| Amber Press LT R20/C2 | 3 | In distribution | |
| Amber Press HT R20/B3 | 3 | In distribution | |
| Amber Press LT R15/D2 | 3 | In distribution | |
| Amber Press HT R7/B3 | 5 | In distribution | |
| Amber Press LT R10/D4 | 5 | In distribution | |
| Amber Press LT R10/D3 | 5 | In distribution | |
| Amber Press MO R20/4 | 3 | In distribution | |
| Amber Press LT R15/B2 | 3 | In distribution | |
| Amber Press LT R15/C1 | 3 | In distribution | |
| Amber Press LT R10/A1 | 5 | In distribution | |
| Amber Press HT R7/B4 | 5 | In distribution | |
| Amber Press LT R7/D4 | 5 | In distribution | |
| Amber Press LT R20/C4 | 3 | In distribution | |
| Amber Press MO R10/4 | 5 | In distribution | |
| Amber Press HT R20/D3 | 3 | In distribution | |
| Amber Press HT R7/A3.5 | 5 | In distribution | |
| Amber Press LT R7/W3 | 5 | In distribution | |
| Amber Press MO R10/3 | 5 | In distribution | |
| Amber Press MO R10/2 | 5 | In distribution | |
| Amber Press HT R15/B2 | 3 | In distribution | |
| Amber Press HT R10/B4 | 5 | In distribution | |
| Amber Press HT R20/A2 | 3 | In distribution | |
| Amber Press LT R15/A4 | 3 | In distribution | |
| Amber Press LT R10/B1 | 5 | In distribution | |
| Amber Press HT R15/W4 | 3 | In distribution | |
| Amber Press HT R10/C4 | 5 | In distribution | |
| Amber Press MO R15/0 | 3 | In distribution | |
| Amber Press HT R20/A2 | 3 | In distribution | |
| Amber Press LT R20/B1 | 3 | In distribution | |
| Amber Press HT R10/A3.5 | 5 | In distribution | |
| Amber Press HT R10/D4 | 5 | In distribution | |
| Amber Press LT R7/D3 | 5 | In distribution | |
| Amber Press HT R20/D4 | 3 | In distribution | |
| Amber Press HT R10/W0 | 5 | In distribution | |
| Amber Press LT R15/W3 | 3 | In distribution | |
| Amber Press HT R10/A3 | 5 | In distribution | |
| Amber Press LT R10/B2 | 5 | In distribution | |
| Amber Press MO R7/0 | 5 | In distribution | |
| Amber Press HT R15/C1 | 3 | In distribution | |
| Amber Press MO R15/2 | 3 | In distribution | |
| Amber Press LT R7/W2 | 5 | In distribution | |
| Amber Press LT R10/W3 | 5 | In distribution | |
| Amber Press LT R7/B3 | 5 | In distribution | |
| Amber Press HT R20/A3.5 | 3 | In distribution | |
| Amber Press LT R10/C3 | 5 | In distribution | |
| Amber Press LT R20/D3 | 3 | In distribution | |
| Amber Press HT R20/C3 | 3 | In distribution | |
| Amber Press HT R10/C2 | 5 | In distribution | |
| Amber Press HT R10/W4 | 5 | In distribution | |
| Amber Press LT R15/C2 | 3 | In distribution | |
| Amber Press HT R7/C3 | 5 | In distribution | |
| Amber Press LT R15/D3 | 3 | In distribution | |
| Amber Press LT R7/B4 | 5 | In distribution | |
| Amber Press LT R15/W4 | 3 | In distribution | |
| Amber Press HT R20/W2 | 3 | In distribution | |
| Amber Press LT R20/A2 | 3 | In distribution | |
| Amber Press LT R15/A2 | 3 | In distribution | |
| Amber Press LT R7/W0 | 5 | In distribution | |
| Amber Press LT R20/W0 | 3 | In distribution | |
| Amber Press LT R20/C1 | 3 | In distribution | |
| Amber Press HT R15/D2 | 3 | In distribution | |
| Amber Press HT R7/D4 | 5 | In distribution | |
| Amber Press LT R15/C4 | 3 | In distribution | |
| Amber Press HT R20/W4 | 3 | In distribution | |
| Amber Press MO R15/4 | 3 | In distribution | |
| Amber Press LT R20/A4 | 3 | In distribution | |
| Amber Press LT R7/W4 | 5 | In distribution | |
| Amber Press HT R7/C2 | 5 | In distribution | |
| Amber Press LT R10/A3.5 | 5 | In distribution | |
| Amber Press HT R20/C1 | 3 | In distribution | |
| Amber Press LT R7/W1 | 5 | In distribution | |
| Amber Press MO R7/1 | 5 | In distribution | |
| Amber Press HT R15/W0 | 3 | In distribution | |
| Amber Press LT R7/B1 | 5 | In distribution | |
| Amber Press HT R20/B1 | 3 | In distribution | |
| Amber Press HT R7/C1 | 5 | In distribution | |
| Amber Press LT R15/C3 | 3 | In distribution | |
| Amber Press LT R20/W1 | 3 | In distribution | |
| Amber Press HT R10/A4 | 5 | In distribution | |
| Amber Press MO R15/1 | 3 | In distribution | |
| Amber Press LT R7/D2 | 5 | In distribution | |
| Amber Press LT R10/W4 | 5 | In distribution | |
| Amber Press HT R20/A3 | 3 | In distribution | |
| Amber Press LT R15/W1 | 3 | In distribution | |
| Amber Press HT R20/A1 | 3 | In distribution | |
| Amber Press LT R20/W4 | 3 | In distribution | |
| Amber Press LT R10/C2 | 5 | In distribution | |
| Amber Press HT R20/C2 | 3 | In distribution | |
| Amber Press LT R15/A3.5 | 3 | In distribution | |
| Amber Press HT R15/C4 | 3 | In distribution | |
| Amber Press MO R10/1 | 5 | In distribution | |
| Amber Press LT R20/A1 | 3 | In distribution | |
| Amber Press HT R7/D2 | 5 | In distribution | |
| Amber Press LT R7/C2 | 5 | In distribution | |
| Amber Press HT R7/W2 | 5 | In distribution | |
| Amber Press LT R15/D4 | 3 | In distribution | |
| Amber Press HT R15/B3 | 3 | In distribution | |
| Amber Press LT R20/W2 | 3 | In distribution | |
| Amber Press MO R10/0 | 5 | In distribution | |
| Amber Press HT R7/B2 | 5 | In distribution | |
| Amber Press HT R7/W0 | 5 | In distribution | |
| Amber Press MO R20/1 | 3 | In distribution | |
| Amber Press HT R15/W1 | 3 | In distribution | |
| Amber Press HT R10/D2 | 5 | In distribution | |
| Amber Press HT R20/W1 | 3 | In distribution | |
| Amber Press HT R7/W3 | 5 | In distribution | |
| Amber Press HT R10/W2 | 5 | In distribution | |
| Amber Press HT R20/A4 | 3 | In distribution | |
| Amber Press LT R20/W3 | 3 | In distribution | |
| Amber Press LT R10/W0 | 5 | In distribution | |
| Amber Press HT R20/W3 | 3 | In distribution | |
| Amber Press LT R7/B2 | 5 | In distribution | |
| Amber Press HT R20/C4 | 3 | In distribution | |
| Amber Press HT R15/W2 | 3 | In distribution | |
| Amber Press HT R15/D3 | 3 | In distribution | |
| Amber Press HT R15/A3.5 | 3 | In distribution | |
| Amber Press MO R7/2 | 5 | In distribution | |
| Amber Press MO R20/3 | 3 | In distribution | |
| Amber Press LT R10/W1 | 5 | In distribution | |
| Amber Press LT R20/B4 | 3 | In distribution | |
| Amber Press MO R7/4 | 5 | In distribution | |
| Amber Press HT R10/A1 | 5 | In distribution | |
| Amber Press HT R15/C2 | 3 | In distribution | |
| Amber Press LT R10/A2 | 5 | In distribution | |
| Amber Press LT R10/B3 | 5 | In distribution | |
| Amber Press LT R20/B3 | 3 | In distribution | |
| Amber Press HT R15/A3 | 3 | In distribution | |
| Amber Press LT R20/B2 | 3 | In distribution | |
| Amber Press LT R10/D2 | 5 | In distribution | |
| Amber Press LT R15/W0 | 3 | In distribution | |
| Amber Press HT R7/A3 | 5 | In distribution | |
| Amber Press LT R7/A1 | 5 | In distribution | |
| Amber Press HT R7/W4 | 5 | In distribution | |
| Amber Press LT R15/A1 | 3 | In distribution | |
| Amber Press HT R15/B4 | 3 | In distribution | |
| Amber Press HT R7/D3 | 5 | In distribution | |
| Amber Press LT R7/C1 | 5 | In distribution | |
| Amber Press HT R10/B2 | 5 | In distribution | |
| Amber Press LT R10/A4 | 5 | In distribution | |
| Amber Press HT R15/W3 | 3 | In distribution | |
| Amber Press HT R7/B1 | 5 | In distribution | |
| Amber Press HT R15/B1 | 3 | In distribution | |
| Amber Press LT R15/B3 | 3 | In distribution | |
| Amber Press HT R10/D3 | 5 | In distribution | |
| Amber Press HT R10/W3 | 5 | In distribution | |
| Amber Press HT R20/B4 | 3 | In distribution | |
| Amber Press LT R7/A3.5 | 5 | In distribution | |
| Amber Press LT R20/A3.5 | 3 | In distribution | |
| Amber Press LT R7/C4 | 5 | In distribution | |
| Amber Press MO R15/3 | 3 | In distribution | |
| Amber Press HT R7/A1 | 5 | In distribution | |
| Amber Press LT R15/B1 | 3 | In distribution | |
| Amber Press LT R20/D2 | 3 | In distribution | |
| Amber Press HT R15/A4 | 3 | In distribution | |
| Amber Press HT R20/B2 | 3 | In distribution | |
| Amber Press HT R15/C3 | 3 | In distribution | |
| Amber Press HT R7/C4 | 5 | In distribution | |
| Amber Press HT R20/W0 | 3 | In distribution | |
| Amber Press HT R7/A2 | 5 | In distribution | |
| Amber Press HT R15/D4 | 3 | In distribution | |
| Amber Press HT R10/A2 | 5 | In distribution | |
| Amber Press LT R20/C3 | 3 | In distribution | |
| Amber Press HT R15/A1 | 3 | In distribution | |
| Amber Press LT R7/C3 | 5 | In distribution | |
| Amber Press LT R10/C4 | 5 | In distribution | |
| Amber Press LT R20/D4 | 3 | In distribution | |
| Amber Press LT R7/A3 | 5 | In distribution | |
| Amber Press LT R7/A2 | 5 | In distribution | |
| Amber Press LT R10/B4 | 5 | In distribution | |
| Amber Press HT R7/A4 | 5 | In distribution | |
| Amber Press MO R7/3 | 5 | In distribution | |
| Amber Press LT R10/C1 | 5 | In distribution | |
| Amber Press LT R15/W2 | 3 | In distribution | |
| Amber Press HT R10/W1 | 5 | In distribution | |
| Amber Press HT R10/B3 | 5 | In distribution |
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.