Zirconia Dental Ceramics
BSM-D98×18 Ttml 0M3
33manufacturers in China registered for this device type
1,828catalogue 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) | K170894 |
| Record published | 2025-09-23 |
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 |
|---|---|---|
| BSM-D98×28 TTML A3 | In distribution | |
| BSM-D98×16 SHTML D4 | In distribution | |
| BSM-D98×28 ST Preshade 3M2 | In distribution | |
| BSM-D98×16 SHTML 2M1 | In distribution | |
| BSM-D98×14 SHTML 5M2 | In distribution | |
| BSM-D98×20 ST Preshade 3R2.5 | In distribution | |
| BSM-D98×10 TTML 2L1.5 | In distribution | |
| BSM-D98×25 STML 3M2 | In distribution | |
| BSM-D98×25 ST Preshade 2L2.5 | In distribution | |
| BSM-D98×30 STML C4 | In distribution | |
| BSM-D98×22 SHTML B4 | In distribution | |
| BSM-D98×12 TTML B2 | In distribution | |
| BSM-D98×22 SHTML B1 | In distribution | |
| BSM-D98×10 STML B2 | In distribution | |
| BSM-D98×12 STML 3L1.5 | In distribution | |
| BSM-D98×25 TTML 4M1 | In distribution | |
| BSM-D98×20 ST Preshade 4R1.5 | In distribution | |
| BSM-D98×28 STML 3R2.5 | In distribution | |
| BSM-D98×22 ST Preshade C4 | In distribution | |
| BSM-D98×18 SHTML 1M2 | In distribution | |
| BSM-D98×12 STML 1M2 | In distribution | |
| BSM-D98×25 ST Preshade 4M1 | In distribution | |
| BSM-D98×10 ST Preshade 2M2 | In distribution | |
| BSM-D98×25 TTML 5M1 | In distribution | |
| BSM-D98×28 STML A3 | In distribution | |
| BSM-D98×16 TTML A3 | In distribution | |
| BSM-D98×14 TTML D3 | In distribution | |
| BSM-D98×14 SHTML 4L1.5 | In distribution | |
| BSM-D98×22 SHTML 0M2 | In distribution | |
| BSM-D98×16 STML A2 | In distribution | |
| BSM-D98×16 SHTML A1 | In distribution | |
| BSM-D98×22 STML B2 | In distribution | |
| BSM-D98×12 SHTML 1M2 | In distribution | |
| BSM-D98×18 ST Preshade 3M2 | In distribution | |
| BSM-D98×28 SHTML 3M2 | In distribution | |
| BSM-D98×12 TTML 3M2 | In distribution | |
| BSM-D98×14 TTML 5M3 | In distribution | |
| BSM-D98×30 ST Preshade 3M2 | In distribution | |
| BSM-D98×10 ST Preshade C3 | In distribution | |
| BSM-D98×14 TTML 1M1 | In distribution | |
| BSM-D98×22 STML 5M3 | In distribution | |
| BSM-D98×30 STML 2L1.5 | In distribution | |
| BSM-D98×20 STML A3.5 | In distribution | |
| BSM-D98×10 SHTML 1M1 | In distribution | |
| BSM-D98×18 SHTML A4 | In distribution | |
| BSM-D98×10 ST Preshade 3M1 | In distribution | |
| BSM-D98×28 SHTML 1M2 | In distribution | |
| BSM-D98×16 STML A3 | In distribution | |
| BSM-D98×16 TTML C1 | In distribution | |
| BSM-D98×30 TTML 0M3 | In distribution | |
| BSM-D98×20 TTML D3 | In distribution | |
| BSM-D98×18 ST Preshade 2R1.5 | In distribution | |
| BSM-D98×10 ST Preshade 4L1.5 | In distribution | |
| BSM-D98×20 ST Preshade 2M1 | In distribution | |
| BSM-D98×30 TTML 4R1.5 | In distribution | |
| BSM-D98×28 STML A3.5 | In distribution | |
| BSM-D98×12 ST Preshade 2M1 | In distribution | |
| BSM-D98×20 ST Preshade 3R1.5 | In distribution | |
| BSM-D98×30 ST Preshade B4 | In distribution | |
| BSM-D98×22 ST Preshade 1M2 | In distribution | |
| BSM-D98×25 SHTML 4L1.5 | In distribution | |
| BSM-D98×22 SHTML D4 | In distribution | |
| BSM-D98×12 STML 4R1.5 | In distribution | |
| BSM-D98×22 TTML 4M2 | In distribution | |
| BSM-D98×12 TTML 4R2.5 | In distribution | |
| BSM-D98×20 SHTML 5M3 | In distribution | |
| BSM-D98×12 STML 3M2 | In distribution | |
| BSM-D98×16 STML 3M1 | In distribution | |
| BSM-D98×25 TTML 3R2.5 | In distribution | |
| BSM-D98×14 SHTML 4M2 | In distribution | |
| BSM-D98×30 TTML 3M2 | In distribution | |
| BSM-D98×18 SHTML C3 | In distribution | |
| BSM-D98×12 STML 4L1.5 | In distribution | |
| BSM-D98×12 ST Preshade B3 | In distribution | |
| BSM-D98×20 STML 3L2.5 | In distribution | |
| BSM-D98×28 STML B3 | In distribution | |
| BSM-D98×10 TTML 4M1 | In distribution | |
| BSM-D98×28 STML 4M2 | In distribution | |
| BSM-D98×22 SHTML 4M1 | In distribution | |
| BSM-D98×10 TTML A1 | In distribution | |
| BSM-D98×16 TTML D3 | In distribution | |
| BSM-D98×12 ST | In distribution | |
| BSM-D98×10 TTML C2 | In distribution | |
| BSM-D98×25 TTML D2 | In distribution | |
| BSM-D98×22 ST Preshade 2M3 | In distribution | |
| BSM-D98×16 ST Preshade D3 | In distribution | |
| BSM-D98×20 STML 2L1.5 | In distribution | |
| BSM-D98×20 ST Preshade 3L2.5 | In distribution | |
| BSM-D98×25 SHTML 2L1.5 | In distribution | |
| BSM-D98×28 ST Preshade 3M1 | In distribution | |
| BSM-D98×10 ST Preshade B4 | In distribution | |
| BSM-D98×18 HT+ | In distribution | |
| BSM-D98×14 SHTML 2R2.5 | In distribution | |
| BSM-D98×10 STML C4 | In distribution | |
| BSM-D98×20 SHTML 3R1.5 | In distribution | |
| BSM-D98×18 TTML A2 | In distribution | |
| BSM-D98×12 TTML C1 | In distribution | |
| BSM-D98×28 TTML 3M3 | In distribution | |
| BSM-D98×28 STML 4M1 | In distribution | |
| BSM-D98×20 SHTML A4 | In distribution | |
| BSM-D98×25 SHTML A3.5 | In distribution | |
| BSM-D98×28 ST Preshade 3M3 | In distribution | |
| BSM-D98×20 TTML 2L2.5 | In distribution | |
| BSM-D98×25 SHTML D3 | In distribution | |
| BSM-D98×16 ST Preshade 2M1 | In distribution | |
| BSM-D98×16 STML 5M1 | In distribution | |
| BSM-D98×30 STML 0M2 | In distribution | |
| BSM-D98×16 STML 5M3 | In distribution | |
| BSM-D98×12 ST Preshade 0M1 | In distribution | |
| BSM-D98×20 ST Preshade B1 | In distribution | |
| BSM-D98×28 ST Preshade 4M2 | In distribution | |
| BSM-D98×10 ST Preshade 5M1 | In distribution | |
| BSM-D98×30 TTML 4M2 | In distribution | |
| BSM-D98×22 SHTML A3.5 | In distribution | |
| BSM-D98×16 STML 0M3 | In distribution | |
| BSM-D98×25 ST Preshade 4R1.5 | In distribution | |
| BSM-D98×18 ST Preshade C3 | In distribution | |
| BSM-D98×30 STML 3R2.5 | In distribution | |
| BSM-D98×20 STML 2M2 | In distribution | |
| BSM-D98×14 TTML 4M1 | In distribution | |
| BSM-D98×25 TTML 1M2 | In distribution | |
| BSM-D98×30 ST | In distribution | |
| BSM-D98×20 SHTML B3 | In distribution | |
| BSM-D98×22 TTML 1M1 | In distribution | |
| BSM-D98×30 STML C1 | In distribution | |
| BSM-D98×16 ST Preshade 2M3 | In distribution | |
| BSM-D98×20 SHTML 2M3 | In distribution | |
| BSM-D98×28 SHTML A3.5 | In distribution | |
| BSM-D98×28 TTML B3 | In distribution | |
| BSM-D98×22 SHTML 3M3 | In distribution | |
| BSM-D98×28 TTML 2L1.5 | In distribution | |
| BSM-D98×16 SHTML C3 | In distribution | |
| BSM-D98×16 ST Preshade B3 | In distribution | |
| BSM-D98×14 TTML A3 | In distribution | |
| BSM-D98×10 SHTML 2M1 | In distribution | |
| BSM-D98×14 TTML 4L1.5 | In distribution | |
| BSM-D98×18 STML 2R2.5 | In distribution | |
| BSM-D98×22 TTML B3 | In distribution | |
| BSM-D98×14 STML 4M1 | In distribution | |
| BSM-D98×25 ST Preshade 3R1.5 | In distribution | |
| BSM-D98×20 SHTML 3R2.5 | In distribution | |
| BSM-D98×20 ST Preshade A3.5 | In distribution | |
| BSM-D98×30 SHTML 3R1.5 | In distribution | |
| BSM-D98×18 SHTML 5M2 | In distribution | |
| BSM-D98×28 TTML B1 | In distribution | |
| BSM-D98×28 SHTML B3 | In distribution | |
| BSM-D98×12 ST Preshade 3R1.5 | In distribution | |
| BSM-D98×18 ST Preshade 1M2 | In distribution | |
| BSM-D98×14 STML B2 | In distribution | |
| BSM-D98×22 TTML 4R2.5 | In distribution | |
| BSM-D98×20 HT+ | In distribution | |
| BSM-D98×18 SHTML B1 | In distribution | |
| BSM-D98×28 STML 4R2.5 | In distribution | |
| BSM-D98×25 SHTML C1 | In distribution | |
| BSM-D98×14 ST Preshade A1 | In distribution | |
| BSM-D98×22 TTML B2 | In distribution | |
| BSM-D98×22 TTML 3L1.5 | In distribution | |
| BSM-D98×12 SHTML 4M2 | In distribution | |
| BSM-D98×22 TTML A1 | In distribution | |
| BSM-D98×22 TTML B1 | In distribution | |
| BSM-D98×10 STML 3M2 | In distribution | |
| BSM-D98×12 ST Preshade D2 | In distribution | |
| BSM-D98×20 STML D3 | In distribution | |
| BSM-D98×10 TTML 1M1 | In distribution | |
| BSM-D98×28 ST Preshade D3 | In distribution | |
| BSM-D98×16 TTML 3L1.5 | In distribution | |
| BSM-D98×18 SHTML 4L2.5 | In distribution | |
| BSM-D98×18 TTML A4 | In distribution | |
| BSM-D98×25 TTML 0M3 | In distribution | |
| BSM-D98×28 SHTML A1 | In distribution | |
| BSM-D98×30 ST Preshade 4R1.5 | In distribution | |
| BSM-D98×18 TTML 5M3 | In distribution | |
| BSM-D98×16 ST Preshade A1 | In distribution | |
| BSM-D98×22 ST Preshade D3 | In distribution | |
| BSM-D98×12 STML 2M3 | In distribution | |
| BSM-D98×20 STML C1 | In distribution | |
| BSM-D98×14 ST Preshade C2 | In distribution | |
| BSM-D98×10 SHTML A3 | In distribution | |
| BSM-D98×12 ST Preshade 2R1.5 | In distribution | |
| BSM-D98×10 SHTML A2 | In distribution | |
| BSM-D98×30 SHTML B3 | In distribution | |
| BSM-D98×30 STML 1M2 | In distribution | |
| BSM-D98×25 TTML 5M2 | In distribution | |
| BSM-D98×14 TTML 2L2.5 | In distribution | |
| BSM-D98×22 STML 0M3 | In distribution | |
| BSM-D98×30 STML 2M2 | In distribution | |
| BSM-D98×30 ST Preshade 4L2.5 | In distribution | |
| BSM-D98×22 TTML 3R2.5 | In distribution | |
| BSM-D98×16 SHTML A4 | In distribution | |
| BSM-D98×14 TTML C4 | In distribution | |
| BSM-D98×12 SHTML 5M1 | In distribution | |
| BSM-D98×20 TTML 2R2.5 | In distribution | |
| BSM-D98×12 SHTML 2R1.5 | In distribution | |
| BSM-D98×20 TTML 4R2.5 | In distribution | |
| BSM-D98×25 STML 0M3 | In distribution | |
| BSM-D98×14 TTML 4M3 | In distribution | |
| BSM-D98×30 STML 4L1.5 | In distribution | |
| BSM-D98×25 TTML 3M3 | In distribution | |
| BSM-D98×22 ST Preshade A4 | In distribution | |
| BSM-D98×22 SHTML 0M3 | In distribution | |
| BSM-D98×30 ST Preshade 2M2 | In distribution | |
| BSM-D98×18 TTML 0M2 | In distribution | |
| BSM-D98×10 SHTML 2M2 | In distribution | |
| BSM-D98×12 SHTML 4R1.5 | In distribution | |
| BSM-D98×20 STML B4 | In distribution | |
| BSM-D98×20 SHTML D3 | In distribution | |
| BSM-D98×10 STML 0M1 | In distribution | |
| BSM-D98×22 STML B3 | In distribution | |
| BSM-D98×20 ST Preshade 4R2.5 | In distribution | |
| BSM-D98×25 SHTML 4M1 | In distribution | |
| BSM-D98×22 STML C2 | In distribution | |
| BSM-D98×14 ST Preshade 3R1.5 | In distribution | |
| BSM-D98×14 ST Preshade C1 | In distribution | |
| BSM-D98×14 STML D4 | In distribution | |
| BSM-D98×16 SHTML 1M2 | In distribution | |
| BSM-D98×25 ST Preshade B1 | In distribution | |
| BSM-D98×12 SHTML 2R2.5 | In distribution | |
| BSM-D98×14 SHTML 3L2.5 | In distribution | |
| BSM-D98×12 ST Preshade 3L2.5 | In distribution | |
| BSM-D98×22 SHTML 3L2.5 | In distribution | |
| BSM-D98×30 SHTML C2 | In distribution | |
| BSM-D98×22 SHTML 3L1.5 | In distribution | |
| BSM-D98×28 STML D3 | In distribution | |
| BSM-D98×12 SHTML 3M2 | In distribution | |
| BSM-D98×28 ST Preshade 3R2.5 | In distribution | |
| BSM-D98×22 ST Preshade 2L2.5 | In distribution | |
| BSM-D98×28 TTML 4L2.5 | In distribution | |
| BSM-D98×20 STML 4R1.5 | In distribution | |
| BSM-D98×16 ST Preshade 5M3 | In distribution | |
| BSM-D98×12 SHTML 3M1 | In distribution | |
| BSM-D98×16 TTML 2L2.5 | In distribution | |
| BSM-D98×30 SHTML 2L2.5 | In distribution | |
| BSM-D98×22 STML A4 | In distribution | |
| BSM-D98×22 ST Preshade B3 | In distribution | |
| BSM-D98×25 SHTML D2 | In distribution | |
| BSM-D98×20 SHTML 0M2 | In distribution | |
| BSM-D98×18 SHTML 2M2 | In distribution | |
| BSM-D98×10 STML A3.5 | In distribution | |
| BSM-D98×12 SHTML 4R2.5 | In distribution | |
| BSM-D98×16 TTML 4M1 | In distribution | |
| BSM-D98×30 TTML A2 | In distribution | |
| BSM-D98×14 SHTML 4M3 | In distribution | |
| BSM-D98×28 ST Preshade B1 | In distribution | |
| BSM-D98×10 STML B3 | In distribution | |
| BSM-D98×20 SHTML 3M1 | In distribution | |
| BSM-D98×12 SHTML 2M1 | In distribution | |
| BSM-D98×10 ST Preshade D3 | In distribution | |
| BSM-D98×25 ST Preshade D2 | In distribution | |
| BSM-D98×16 TTML A4 | In distribution | |
| BSM-D98×30 TTML 4L2.5 | In distribution |
Showing 250 of 300 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 |
| 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 |
| IPS e.max CAD | Ivoclar Vivadent Aktiengesellschaft | 1,045 |
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.