Polystar Selection Edition HD
posteriors; shade A3.5; size XL; upper jaw
26manufacturers in China registered for this device type
160catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Fuzhou Delphin BIO-Tech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 18 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Heyuan HEY White Technology Co., Ltd. | Heyuan | Guangdong | Manufacturer | 12 |
| Beijing Yingguan Dental Science&Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 11 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth
Record
| Listed by | Merz Dental Gmbh, Germany |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Manufacturer |
| 510(k) | K120404 |
| Record published | 2017-01-06 |
| Record revised | 2025-01-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| posteriors; shade B1; size XL; upper jaw | In distribution | |
| posteriors; shade A1; size L; upper jaw | In distribution | |
| posteriors; shade D3; size S; lower jaw | In distribution | |
| posteriors; shade BL3; size L; lower jaw | In distribution | |
| posteriors; shade BL4; size S; lower jaw | In distribution | |
| posteriors; shade C3; size S; upper jaw | In distribution | |
| posteriors; shade D3; size M; lower jaw | In distribution | |
| posteriors; shade B1; size M; upper jaw | In distribution | |
| posteriors; shade BL2; size L; lower jaw | In distribution | |
| posteriors; shade A4; size XL; upper jaw | In distribution | |
| posteriors; shade B3; size M; upper jaw | In distribution | |
| posteriors; shade C2; size M; upper jaw | In distribution | |
| posteriors; shade D2; size M; upper jaw | In distribution | |
| posteriors; shade A2; size S; lower jaw | In distribution | |
| posteriors; shade B2; size XL; lower jaw | In distribution | |
| posteriors; shade A4; size M; upper jaw | In distribution | |
| posteriors; shade BL1; size M; upper jaw | In distribution | |
| posteriors; shade D2; size XL; lower jaw | In distribution | |
| posteriors; shade A3; size XL; lower jaw | In distribution | |
| posteriors; shade C2; size XL; lower jaw | In distribution | |
| posteriors; shade BL2; size L; upper jaw | In distribution | |
| posteriors; shade A2; size L; lower jaw | In distribution | |
| posteriors; shade D3; size S; upper jaw | In distribution | |
| posteriors; shade A3; size S; lower jaw | In distribution | |
| posteriors; shade C2; size M; lower jaw | In distribution | |
| posteriors; shade C4; size M; upper jaw | In distribution | |
| posteriors; shade A3.5; size M; lower jaw | In distribution | |
| posteriors; shade BL3; size XL; upper jaw | In distribution | |
| posteriors; shade A3; size XL; upper jaw | In distribution | |
| posteriors; shade A1; size XL; upper jaw | In distribution | |
| posteriors; shade BL4; size XL; lower jaw | In distribution | |
| posteriors; shade B2; size M; upper jaw | In distribution | |
| posteriors; shade BL2; size S; upper jaw | In distribution | |
| posteriors; shade A3.5; size S; upper jaw | In distribution | |
| posteriors; shade D2; size S; lower jaw | In distribution | |
| posteriors; shade C1; size M; upper jaw | In distribution | |
| posteriors; shade D4; size L; lower jaw | In distribution | |
| posteriors; shade C4; size S; upper jaw | In distribution | |
| posteriors; shade C4; size L; lower jaw | In distribution | |
| posteriors; shade C2; size L; lower jaw | In distribution | |
| posteriors; shade A1; size XL; lower jaw | In distribution | |
| posteriors; shade BL3; size L; upper jaw | In distribution | |
| posteriors; shade B2; size S; lower jaw | In distribution | |
| posteriors; shade A3; size M; upper jaw | In distribution | |
| posteriors; shade D4; size XL; lower jaw | In distribution | |
| posteriors; shade A1; size S; lower jaw | In distribution | |
| posteriors; shade D4; size M; lower jaw | In distribution | |
| posteriors; shade B3; size M; lower jaw | In distribution | |
| posteriors; shade A4; size M; lower jaw | In distribution | |
| posteriors; shade B1; size L; upper jaw | In distribution | |
| posteriors; shade BL4; size M; lower jaw | In distribution | |
| posteriors; shade C1; size L; upper jaw | In distribution | |
| posteriors; shade B4; size XL; upper jaw | In distribution | |
| posteriors; shade D4; size M; upper jaw | In distribution | |
| posteriors; shade D4; size S; upper jaw | In distribution | |
| posteriors; shade BL3; size M; upper jaw | In distribution | |
| posteriors; shade B1; size S; lower jaw | In distribution | |
| posteriors; shade BL1; size XL; upper jaw | In distribution | |
| posteriors; shade B3; size S; upper jaw | In distribution | |
| posteriors; shade C4; size L; upper jaw | In distribution | |
| posteriors; shade A3; size L; upper jaw | In distribution | |
| posteriors; shade B3; size XL; upper jaw | In distribution | |
| posteriors; shade A3.5; size L; lower jaw | In distribution | |
| posteriors; shade C3; size L; lower jaw | In distribution | |
| posteriors; shade C4; size S; lower jaw | In distribution | |
| posteriors; shade B2; size L; upper jaw | In distribution | |
| posteriors; shade A1; size S; upper jaw | In distribution | |
| posteriors; shade B4; size M; upper jaw | In distribution | |
| posteriors; shade BL1; size S; upper jaw | In distribution | |
| posteriors; shade B2; size XL; upper jaw | In distribution | |
| posteriors; shade A4; size S; lower jaw | In distribution | |
| posteriors; shade C3; size S; lower jaw | In distribution | |
| posteriors; shade D2; size L; lower jaw | In distribution | |
| posteriors; shade D3; size XL; lower jaw | In distribution | |
| posteriors; shade D4; size S; lower jaw | In distribution | |
| posteriors; shade A1; size M; lower jaw | In distribution | |
| posteriors; shade BL4; size L; lower jaw | In distribution | |
| posteriors; shade D4; size L; upper jaw | In distribution | |
| posteriors; shade A4; size L; lower jaw | In distribution | |
| posteriors; shade BL2; size M; upper jaw | In distribution | |
| posteriors; shade BL1; size M; lower jaw | In distribution | |
| posteriors; shade B4; size L; upper jaw | In distribution | |
| posteriors; shade C1; size S; lower jaw | In distribution | |
| posteriors; shade D2; size M; lower jaw | In distribution | |
| posteriors; shade A3.5; size XL; upper jaw | In distribution | |
| posteriors; shade A2; size XL; lower jaw | In distribution | |
| posteriors; shade A3.5; size L; upper jaw | In distribution | |
| posteriors; shade BL4; size XL; upper jaw | In distribution | |
| posteriors; shade C2; size XL; upper jaw | In distribution | |
| posteriors; shade A3.5; size S; lower jaw | In distribution | |
| posteriors; shade A2; size M; upper jaw | In distribution | |
| posteriors; shade C3; size XL; lower jaw | In distribution | |
| posteriors; shade C4; size XL; upper jaw | In distribution | |
| posteriors; shade BL1; size S; lower jaw | In distribution | |
| posteriors; shade BL3; size XL; lower jaw | In distribution | |
| posteriors; shade B4; size XL; lower jaw | In distribution | |
| posteriors; shade A2; size L; upper jaw | In distribution | |
| posteriors; shade A2; size XL; upper jaw | In distribution | |
| posteriors; shade C3; size M; lower jaw | In distribution | |
| posteriors; shade C1; size M; lower jaw | In distribution | |
| posteriors; shade BL3; size S; upper jaw | In distribution | |
| posteriors; shade D2; size S; upper jaw | In distribution | |
| posteriors; shade D2; size L; upper jaw | In distribution | |
| posteriors; shade B3; size S; lower jaw | In distribution | |
| posteriors; shade D3; size L; upper jaw | In distribution | |
| posteriors; shade A2; size S; upper jaw | In distribution | |
| posteriors; shade D3; size XL; upper jaw | In distribution | |
| posteriors; shade A3; size L; lower jaw | In distribution | |
| posteriors; shade D3; size M; upper jaw | In distribution | |
| posteriors; shade C4; size XL; lower jaw | In distribution | |
| posteriors; shade B1; size S; upper jaw | In distribution | |
| posteriors; shade A3.5; size M; upper jaw | In distribution | |
| posteriors; shade BL1; size XL; lower jaw | In distribution | |
| posteriors; shade B2; size M; lower jaw | In distribution | |
| posteriors; shade A1; size M; upper jaw | In distribution | |
| posteriors; shade C1; size XL; upper jaw | In distribution | |
| posteriors; shade B3; size XL; lower jaw | In distribution | |
| posteriors; shade D3; size L; lower jaw | In distribution | |
| posteriors; shade B1; size XL; lower jaw | In distribution | |
| posteriors; shade A3; size M; lower jaw | In distribution | |
| posteriors; shade BL1; size L; upper jaw | In distribution | |
| posteriors; shade BL4; size S; upper jaw | In distribution | |
| posteriors; shade BL2; size XL; upper jaw | In distribution | |
| posteriors; shade BL2; size XL; lower jaw | In distribution | |
| posteriors; shade A3; size S; upper jaw | In distribution | |
| posteriors; shade B4; size S; lower jaw | In distribution | |
| posteriors; shade B2; size S; upper jaw | In distribution | |
| posteriors; shade BL4; size L; upper jaw | In distribution | |
| posteriors; shade A4; size S; upper jaw | In distribution | |
| posteriors; shade BL4; size M; upper jaw | In distribution | |
| posteriors; shade B4; size L; lower jaw | In distribution | |
| posteriors; shade D4; size XL; upper jaw | In distribution | |
| posteriors; shade C3; size M; upper jaw | In distribution | |
| posteriors; shade BL2; size M; lower jaw | In distribution | |
| posteriors; shade BL3; size M; lower jaw | In distribution | |
| posteriors; shade A4; size L; upper jaw | In distribution | |
| posteriors; shade A3.5; size XL; lower jaw | In distribution | |
| posteriors; shade A2; size M; lower jaw | In distribution | |
| posteriors; shade B4; size M; lower jaw | In distribution | |
| posteriors; shade BL1; size L; lower jaw | In distribution | |
| posteriors; shade C1; size XL; lower jaw | In distribution | |
| posteriors; shade C3; size XL; upper jaw | In distribution | |
| posteriors; shade C1; size S; upper jaw | In distribution | |
| posteriors; shade D2; size XL; upper jaw | In distribution | |
| posteriors; shade A4; size XL; lower jaw | In distribution | |
| posteriors; shade C2; size S; lower jaw | In distribution | |
| posteriors; shade B2; size L; lower jaw | In distribution | |
| posteriors; shade B1; size M; lower jaw | In distribution | |
| posteriors; shade A1; size L; lower jaw | In distribution | |
| posteriors; shade C3; size L; upper jaw | In distribution | |
| posteriors; shade B3; size L; upper jaw | In distribution | |
| posteriors; shade C2; size L; upper jaw | In distribution | |
| posteriors; shade C1; size L; lower jaw | In distribution | |
| posteriors; shade B3; size L; lower jaw | In distribution | |
| posteriors; shade B4; size S; upper jaw | In distribution | |
| posteriors; shade BL3; size S; lower jaw | In distribution | |
| posteriors; shade BL2; size S; lower jaw | In distribution | |
| posteriors; shade C4; size M; lower jaw | In distribution | |
| posteriors; shade B1; size L; lower jaw | In distribution | |
| posteriors; shade C2; size S; upper jaw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resin Teeth DCL PE | Ivoclar Vivadent Aktiengesellschaft | 8,657 |
| Primodent | Polident d.o.o. | 3,814 |
| Resin Teeth S PE S DCL | Ivoclar Vivadent Aktiengesellschaft | 2,870 |
| Vitapan | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2,480 |
| Myerson Special | The Myerson Company Limited | 2,386 |
| Kenson | The Myerson Company Limited | 2,365 |
| Candulor TCR | Candulor, AG | 1,944 |
| Vita Physiodens | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 1,788 |
| Portrait® IPN® Anteriors | Dentsply LLC | 1,674 |
| Enigma Denture Teeth – Pairs | Davis Schottlander & Davis, Ltd. | 1,632 |
| Ivostar Gnathostar | Ivoclar Vivadent Aktiengesellschaft | 1,501 |
| REF-Line | Polident d.o.o. | 1,458 |
Showing 12 of 9,979. All products under Denture, Plastic, Teeth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120404 | 2012-05-21 |
| K030588 | 2003-05-07 |
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.