Dental Glass Ceramics
Besmile Dental Glass Ceramics is a material range for making all-ceramic dental restorations. It supports hot-press fabrication or CAD/CAM machining for veneers, inlays, onlays, partial…
Besmile Dental Glass Ceramics is a material range for making all-ceramic dental restorations. It supports hot-press fabrication or CAD/CAM machining for veneers, inlays, onlays, partial crowns and anterior or posterior crowns.
For the CAD/CAM route, a scanned model or oral preparation supplies a three-dimensional data set. Software defines the restoration, and computer-controlled machining tools shape the ceramic to that design.
Material and Finishing
The glass ceramic contains silica, alumina, lithium oxide and other oxides. It is compatible with grinding and polishing equipment, so the formed restoration can be finished after the main shaping step. Hot pressing and milling are distinct fabrication routes within the range.
33manufacturers in China registered for this device type
192catalogue 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.
| 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 | 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) | K232673 |
| Record published | 2025-08-12 |
| Record revised | 2025-09-02 (version 2) |
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 number | Size | Status |
|---|---|---|
| HT A2 12.5×15 | In distribution | |
| LT A3.5 12.5×13 | In distribution | |
| HT C2 12.5×13 | In distribution | |
| HT A3 12.5×13 | In distribution | |
| HT B2 12.5×11 | In distribution | |
| LT B2 12.5×17 | In distribution | |
| LT 0M1 12.5×17 | In distribution | |
| LT 0M1 18.5×17.9×12.5 | In distribution | |
| LT 0M1 12.5×15 | In distribution | |
| LT B1 12.5×15 | In distribution | |
| LT 0M1 40×15×14 | In distribution | |
| HT B2 12.5×13 | In distribution | |
| HT C2 12.5×11 | In distribution | |
| LT A3.5 18.5×17.9×12.5 | In distribution | |
| LT D2 12.5×17 | In distribution | |
| HT 0M3 18.5×17.9×12.5 | In distribution | |
| HT 0M2 18.5×17.9×12.5 | In distribution | |
| HT A3.5 12.5×17 | In distribution | |
| HT A1 18.5×17.9×12.5 | In distribution | |
| LT B3 18.5×14.9×12.5 | In distribution | |
| HT B3 18.5×17.9×12.5 | In distribution | |
| LT B1 12.5×11 | In distribution | |
| LT B1 12.5×17 | In distribution | |
| HT A3 18.5×17.9×12.5 | In distribution | |
| LT B1 40×15×14 | In distribution | |
| HT 0M1 18.5×17.9×12.5 | In distribution | |
| HT D2 18.5×14.9×12.5 | In distribution | |
| HT B3 12.5×15 | In distribution | |
| LT 0M2 12.5×13 | In distribution | |
| HT D2 40×15×14 | In distribution | |
| LT D2 18.5×17.9×12.5 | In distribution | |
| LT 0M2 18.5×14.9×12.5 | In distribution | |
| LT 0M1 12.5×13 | In distribution | |
| LT 0M3 18.5×17.9×12.5 | In distribution | |
| HT A1 18.5×14.9×12.5 | In distribution | |
| HT C2 18.5×16.9×12.5 | In distribution | |
| LT A3 12.5×15 | In distribution | |
| HT B1 18.5×16.9×12.5 | In distribution | |
| HT B2 40×15×14 | In distribution | |
| LT C2 18.5×14.9×12.5 | In distribution | |
| LT 0M1 12.5×11 | In distribution | |
| LT A3.5 12.5×11 | In distribution | |
| LT D2 18.5×14.9×12.5 | In distribution | |
| LT 0M1 18.5×16.9×12.5 | In distribution | |
| HT A3.5 12.5×15 | In distribution | |
| LT C2 40×15×14 | In distribution | |
| HT 0M3 12.5×15 | In distribution | |
| HT 0M3 40×15×14 | In distribution | |
| LT C2 18.5×16.9×12.5 | In distribution | |
| HT B1 12.5×15 | In distribution | |
| HT D2 18.5×16.9×12.5 | In distribution | |
| LT 0M2 40×15×14 | In distribution | |
| HT D2 12.5×13 | In distribution | |
| LT A3.5 18.5×14.9×12.5 | In distribution | |
| LT 0M2 12.5×11 | In distribution | |
| HT B3 12.5×13 | In distribution | |
| HT B3 40×15×14 | In distribution | |
| LT A2 18.5×16.9×12.5 | In distribution | |
| HT A3 12.5×11 | In distribution | |
| LT 0M2 18.5×16.9×12.5 | In distribution | |
| LT B2 18.5×16.9×12.5 | In distribution | |
| LT A2 12.5×15 | In distribution | |
| HT B3 18.5×14.9×12.5 | In distribution | |
| LT 0M3 40×15×14 | In distribution | |
| HT A3.5 18.5×17.9×12.5 | In distribution | |
| HT B3 12.5×17 | In distribution | |
| LT A3 40×15×14 | In distribution | |
| LT A1 12.5×13 | In distribution | |
| LT D2 40×15×14 | In distribution | |
| LT C2 12.5×13 | In distribution | |
| LT 0M3 18.5×14.9×12.5 | In distribution | |
| LT C2 12.5×11 | In distribution | |
| LT B2 12.5×13 | In distribution | |
| HT B1 18.5×17.9×12.5 | In distribution | |
| HT 0M2 40×15×14 | In distribution | |
| LT 0M3 18.5×16.9×12.5 | In distribution | |
| LT A3 12.5×11 | In distribution | |
| HT A1 40×15×14 | In distribution | |
| HT A3 18.5×14.9×12.5 | In distribution | |
| LT A3.5 18.5×16.9×12.5 | In distribution | |
| HT A3 18.5×16.9×12.5 | In distribution | |
| HT 0M2 18.5×16.9×12.5 | In distribution | |
| HT 0M3 12.5×13 | In distribution | |
| LT B1 18.5×16.9×12.5 | In distribution | |
| LT B2 12.5×11 | In distribution | |
| HT A1 12.5×13 | In distribution | |
| LT A1 18.5×17.9×12.5 | In distribution | |
| LT D2 12.5×15 | In distribution | |
| HT 0M2 12.5×17 | In distribution | |
| LT A3 12.5×17 | In distribution | |
| LT A3 18.5×17.9×12.5 | In distribution | |
| HT B1 12.5×17 | In distribution | |
| HT A3 12.5×15 | In distribution | |
| HT 0M2 12.5×15 | In distribution | |
| LT B2 12.5×15 | In distribution | |
| HT B2 18.5×16.9×12.5 | In distribution | |
| HT B3 12.5×11 | In distribution | |
| HT A3.5 18.5×16.9×12.5 | In distribution | |
| LT B2 18.5×17.9×12.5 | In distribution | |
| HT A1 12.5×15 | In distribution | |
| LT A3.5 12.5×17 | In distribution | |
| HT D2 12.5×15 | In distribution | |
| HT B3 18.5×16.9×12.5 | In distribution | |
| HT 0M1 12.5×13 | In distribution | |
| LT 0M1 18.5×14.9×12.5 | In distribution | |
| LT 0M2 12.5×15 | In distribution | |
| LT B2 40×15×14 | In distribution | |
| HT A2 12.5×13 | In distribution | |
| LT A1 40×15×14 | In distribution | |
| HT 0M1 12.5×15 | In distribution | |
| LT B3 18.5×17.9×12.5 | In distribution | |
| HT B2 12.5×17 | In distribution | |
| HT D2 12.5×11 | In distribution | |
| HT A2 18.5×17.9×12.5 | In distribution | |
| HT A3 12.5×17 | In distribution | |
| HT 0M2 18.5×14.9×12.5 | In distribution | |
| LT B1 18.5×17.9×12.5 | In distribution | |
| LT B2 18.5×14.9×12.5 | In distribution | |
| HT 0M3 12.5×11 | In distribution | |
| LT B3 12.5×17 | In distribution | |
| HT C2 40×15×14 | In distribution | |
| HT 0M2 12.5×13 | In distribution | |
| HT 0M1 18.5×14.9×12.5 | In distribution | |
| LT B3 12.5×11 | In distribution | |
| HT C2 18.5×17.9×12.5 | In distribution | |
| LT C2 12.5×15 | In distribution | |
| LT A1 12.5×17 | In distribution | |
| LT B1 18.5×14.9×12.5 | In distribution | |
| HT D2 12.5×17 | In distribution | |
| LT A2 12.5×13 | In distribution | |
| LT B1 12.5×13 | In distribution | |
| HT A2 18.5×16.9×12.5 | In distribution | |
| LT 0M3 12.5×17 | In distribution | |
| LT B3 40×15×14 | In distribution | |
| LT A2 18.5×17.9×12.5 | In distribution | |
| HT A1 12.5×11 | In distribution | |
| HT A2 40×15×14 | In distribution | |
| LT A3 18.5×16.9×12.5 | In distribution | |
| LT B3 12.5×15 | In distribution | |
| HT B1 12.5×11 | In distribution | |
| HT A2 12.5×17 | In distribution | |
| HT A3.5 12.5×13 | In distribution | |
| HT B2 12.5×15 | In distribution | |
| HT C2 18.5×14.9×12.5 | In distribution | |
| HT 0M3 12.5×17 | In distribution | |
| LT D2 12.5×13 | In distribution | |
| LT C2 12.5×17 | In distribution | |
| HT 0M1 18.5×16.9×12.5 | In distribution | |
| LT A3.5 40×15×14 | In distribution | |
| HT B1 12.5×13 | In distribution | |
| LT B3 12.5×13 | In distribution | |
| LT D2 18.5×16.9×12.5 | In distribution | |
| HT A3.5 40×15×14 | In distribution | |
| HT A3.5 12.5×11 | In distribution | |
| LT 0M3 12.5×11 | In distribution | |
| HT A2 18.5×14.9×12.5 | In distribution | |
| HT 0M1 12.5×11 | In distribution | |
| HT A1 18.5×16.9×12.5 | In distribution | |
| LT A1 18.5×16.9×12.5 | In distribution | |
| HT 0M1 40×15×14 | In distribution | |
| LT 0M3 12.5×13 | In distribution | |
| HT A2 12.5×11 | In distribution | |
| HT D2 18.5×17.9×12.5 | In distribution | |
| HT B2 18.5×14.9×12.5 | In distribution | |
| HT B1 18.5×14.9×12.5 | In distribution | |
| HT A3 40×15×14 | In distribution | |
| HT C2 12.5×17 | In distribution | |
| HT 0M3 18.5×16.9×12.5 | In distribution | |
| LT 0M3 12.5×15 | In distribution | |
| LT A1 12.5×15 | In distribution | |
| HT A1 12.5×17 | In distribution | |
| LT A2 40×15×14 | In distribution | |
| LT 0M2 18.5×17.9×12.5 | In distribution | |
| LT A1 12.5×11 | In distribution | |
| LT A1 18.5×14.9×12.5 | In distribution | |
| LT A2 18.5×14.9×12.5 | In distribution | |
| LT B3 18.5×16.9×12.5 | In distribution | |
| LT A2 12.5×11 | In distribution | |
| LT A3 12.5×13 | In distribution | |
| LT C2 18.5×17.9×12.5 | In distribution | |
| LT A3 18.5×14.9×12.5 | In distribution | |
| HT B2 18.5×17.9×12.5 | In distribution | |
| HT 0M3 18.5×14.9×12.5 | In distribution | |
| HT C2 12.5×15 | In distribution | |
| LT D2 12.5×11 | In distribution | |
| HT 0M1 12.5×17 | In distribution | |
| HT 0M2 12.5×11 | In distribution | |
| HT B1 40×15×14 | In distribution | |
| HT A3.5 18.5×14.9×12.5 | In distribution | |
| LT A2 12.5×17 | In distribution | |
| LT 0M2 12.5×17 | In distribution | |
| LT A3.5 12.5×15 | 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 |
|---|---|
| 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.