Polystar Selection Edition
posteriors; shade A3.5 light; size XL; upper jaw
26manufacturers in China registered for this device type
950catalogue 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) | K030588 |
| Record published | 2016-12-31 |
| Record revised | 2025-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| anteriors; shade A4; mould BIS2 | In distribution | |
| anteriors; shade D4; mould CM6 | In distribution | |
| anteriors; shade D3 light; mould BM4 | In distribution | |
| anteriors; shade C3; mould CM6 | In distribution | |
| posteriors; shade C1; size L; lower jaw | In distribution | |
| anteriors; shade A1; mould BIM6 | In distribution | |
| anteriors; shade C3; mould BS2 | In distribution | |
| anteriors; shade A2; mould UM8 | In distribution | |
| anteriors; shade A3; mould US2 | In distribution | |
| anteriors; shade BL4; mould IL2 | In distribution | |
| anteriors; shade B1; mould IM6 | In distribution | |
| anteriors; shade D3 light; mould BIM2 | In distribution | |
| anteriors; shade C2; mould BS2 | In distribution | |
| anteriors; shade D4; mould IS2 | In distribution | |
| anteriors; shade C3; mould CS2 | In distribution | |
| anteriors; shade B3; mould CM4 | In distribution | |
| anteriors; shade D3; mould UM10 | In distribution | |
| anteriors; shade A1; mould BIS2 | In distribution | |
| posteriors; shade D3 light; size L; upper jaw | In distribution | |
| posteriors; shade A2; size L; lower jaw | In distribution | |
| posteriors; shade A2 light; size XL; upper jaw | In distribution | |
| anteriors; shade B3; mould IS2 | In distribution | |
| posteriors; shade BL2; size S; upper jaw | In distribution | |
| anteriors; shade D3; mould IL2 | In distribution | |
| anteriors; shade A2 light; mould IL2 | In distribution | |
| posteriors; shade A2; size L; upper jaw | In distribution | |
| posteriors; shade A3.5; size XL; lower jaw | In distribution | |
| anteriors; shade D3 light; mould UL2 | In distribution | |
| anteriors; shade C4; mould CM2 | In distribution | |
| anteriors; shade D2 light; mould BM6 | In distribution | |
| anteriors; shade C1; mould BIL2 | In distribution | |
| anteriors; shade B2; mould IM6 | In distribution | |
| anteriors; shade D4; mould IM6 | In distribution | |
| anteriors; shade D2; mould BM2 | In distribution | |
| anteriors; shade B3; mould IM6 | In distribution | |
| anteriors; shade BL3; mould BIL1 | In distribution | |
| anteriors; shade B4; mould BL2 | In distribution | |
| posteriors; shade D3; size XL; upper jaw | In distribution | |
| anteriors; shade C4; mould BIS2 | In distribution | |
| anteriors; shade A4; mould UM6 | In distribution | |
| anteriors; shade A3; mould CL2 | In distribution | |
| anteriors; shade BL4; mould IS2 | In distribution | |
| posteriors; shade A1; size S; lower jaw | In distribution | |
| anteriors; shade A3 light; mould UM6 | In distribution | |
| anteriors; shade D3 light; mould UM6 | In distribution | |
| anteriors; shade A3.5; mould BIM6 | In distribution | |
| anteriors; shade D4; mould BIM6 | In distribution | |
| anteriors; shade C3; mould CM4 | In distribution | |
| anteriors; shade A4; mould BM2 | In distribution | |
| anteriors; shade C3; mould BM2 | In distribution | |
| posteriors; shade A4; size XL; upper jaw | In distribution | |
| anteriors; shade A3; mould BM4 | In distribution | |
| anteriors; shade BL2; mould UL2 | In distribution | |
| anteriors; shade D2; mould BM4 | In distribution | |
| anteriors; shade BL4; mould UM4 | In distribution | |
| anteriors; shade D2; mould BIM4 | In distribution | |
| anteriors; shade D3; mould CM4 | In distribution | |
| anteriors; shade C1; mould UM10 | In distribution | |
| anteriors; shade C2; mould UL4 | In distribution | |
| anteriors; shade BL1; mould BM6 | In distribution | |
| anteriors; shade BL4; mould BM6 | In distribution | |
| anteriors; shade D3; mould BIL2 | In distribution | |
| anteriors; shade A2; mould BIL2 | In distribution | |
| anteriors; shade A3 light; mould BM2 | In distribution | |
| anteriors; shade D3 light; mould BM2 | In distribution | |
| anteriors; shade D3; mould CL2 | In distribution | |
| anteriors; shade A3.5; mould UL4 | In distribution | |
| anteriors; shade D3; mould BL2 | In distribution | |
| anteriors; shade B1; mould CM6 | In distribution | |
| anteriors; shade B4; mould CM6 | In distribution | |
| anteriors; shade A3 light; mould UM10 | In distribution | |
| anteriors; shade C4; mould IL2 | In distribution | |
| anteriors; shade BL2; mould UM6 | In distribution | |
| anteriors; shade B1; mould UL4 | In distribution | |
| posteriors; shade A3; size M; upper jaw | In distribution | |
| posteriors; shade A4; size S; upper jaw | In distribution | |
| anteriors; shade A2; mould CM2 | In distribution | |
| anteriors; shade C3; mould BIM4 | In distribution | |
| anteriors; shade A3; mould UL4 | In distribution | |
| anteriors; shade A3.5; mould CM4 | In distribution | |
| anteriors; shade C1; mould CM4 | In distribution | |
| posteriors; shade B2; size S; lower jaw | In distribution | |
| anteriors; shade A4; mould CS2 | In distribution | |
| posteriors; shade C4; size L; upper jaw | In distribution | |
| anteriors; shade B1; mould BIL1 | In distribution | |
| anteriors; shade A3.5; mould IS2 | In distribution | |
| anteriors; shade B3; mould CS2 | In distribution | |
| posteriors; shade A2 light; size M; lower jaw | In distribution | |
| anteriors; shade C3; mould BM6 | In distribution | |
| anteriors; shade D2; mould US4 | In distribution | |
| anteriors; shade C4; mould UM4 | In distribution | |
| anteriors; shade B3; mould IM2 | In distribution | |
| anteriors; shade D2; mould BIM6 | In distribution | |
| posteriors; shade C3; size S; upper jaw | In distribution | |
| anteriors; shade A1; mould UL2 | In distribution | |
| anteriors; shade A3.5; mould UL2 | In distribution | |
| anteriors; shade D3 light; mould BL2 | In distribution | |
| posteriors; shade D2 light; size S; lower jaw | In distribution | |
| anteriors; shade BL4; mould BS2 | In distribution | |
| anteriors; shade D3; mould IM2 | In distribution | |
| anteriors; shade BL4; mould CL2 | In distribution | |
| posteriors; shade A2 light; size L; lower jaw | In distribution | |
| anteriors; shade A3.5; mould BL2 | In distribution | |
| anteriors; shade D3 light; mould CM4 | In distribution | |
| anteriors; shade BL3; mould UM10 | In distribution | |
| anteriors; shade B3; mould BIM2 | In distribution | |
| anteriors; shade B4; mould US4 | In distribution | |
| anteriors; shade A2; mould BL2 | In distribution | |
| anteriors; shade A2; mould IS2 | In distribution | |
| anteriors; shade B4; mould US2 | In distribution | |
| posteriors; shade BL1; size M; lower jaw | In distribution | |
| anteriors; shade A3; mould CM4 | In distribution | |
| anteriors; shade B1; mould CM4 | In distribution | |
| anteriors; shade B4; mould CM4 | In distribution | |
| posteriors; shade D4; size M; lower jaw | In distribution | |
| anteriors; shade BL1; mould BIM4 | In distribution | |
| anteriors; shade A3.5 light; mould BIM4 | In distribution | |
| posteriors; shade D2 light; size S; upper jaw | In distribution | |
| anteriors; shade BL1; mould BL2 | In distribution | |
| posteriors; shade C2; size M; lower jaw | In distribution | |
| posteriors; shade B4; size M; lower jaw | In distribution | |
| anteriors; shade BL2; mould IL2 | In distribution | |
| anteriors; shade BL3; mould UM2 | In distribution | |
| anteriors; shade B1; mould UM10 | In distribution | |
| anteriors; shade BL4; mould BL2 | In distribution | |
| anteriors; shade BL1; mould CM4 | In distribution | |
| anteriors; shade A3.5; mould BIM4 | In distribution | |
| anteriors; shade D4; mould BIM4 | In distribution | |
| posteriors; shade B4; size L; upper jaw | In distribution | |
| posteriors; shade D3; size M; upper jaw | In distribution | |
| anteriors; shade B4; mould UM6 | In distribution | |
| anteriors; shade C3; mould UM6 | In distribution | |
| anteriors; shade A2 light; mould BM2 | In distribution | |
| anteriors; shade B3; mould BS2 | In distribution | |
| anteriors; shade BL2; mould UM2 | In distribution | |
| anteriors; shade A3 light; mould US4 | In distribution | |
| anteriors; shade A2 light; mould CM2 | In distribution | |
| anteriors; shade C1; mould UM8 | In distribution | |
| anteriors; shade BL2; mould IS2 | In distribution | |
| anteriors; shade C2; mould CM2 | In distribution | |
| anteriors; shade D4; mould UM10 | In distribution | |
| anteriors; shade BL2; mould CS2 | In distribution | |
| anteriors; shade D3; mould BIM4 | In distribution | |
| anteriors; shade C1; mould CL2 | In distribution | |
| posteriors; shade B2; size M; lower jaw | In distribution | |
| posteriors; shade A3 light; size XL; lower jaw | In distribution | |
| anteriors; shade A1; mould CM6 | In distribution | |
| anteriors; shade A3 light; mould UM4 | In distribution | |
| anteriors; shade D3 light; mould UM4 | In distribution | |
| anteriors; shade A4; mould UL2 | In distribution | |
| posteriors; shade D2; size S; upper jaw | In distribution | |
| anteriors; shade A2; mould BIL1 | In distribution | |
| anteriors; shade A2 light; mould BIL2 | In distribution | |
| anteriors; shade A2 light; mould UM10 | In distribution | |
| anteriors; shade A2; mould CS2 | In distribution | |
| anteriors; shade A2 light; mould IS2 | In distribution | |
| anteriors; shade D3 light; mould BIM4 | In distribution | |
| anteriors; shade A3; mould BIS2 | In distribution | |
| anteriors; shade B1; mould IS2 | In distribution | |
| posteriors; shade B1; size S; upper jaw | In distribution | |
| posteriors; shade D3; size M; lower jaw | In distribution | |
| anteriors; shade A2 light; mould BIM6 | In distribution | |
| posteriors; shade A2; size XL; upper jaw | In distribution | |
| anteriors; shade A2; mould CM4 | In distribution | |
| anteriors; shade C1; mould US2 | In distribution | |
| anteriors; shade C1; mould UM4 | In distribution | |
| posteriors; shade BL4; size S; upper jaw | In distribution | |
| anteriors; shade D3; mould UL4 | In distribution | |
| anteriors; shade B1; mould BIS2 | In distribution | |
| anteriors; shade C3; mould BIS2 | In distribution | |
| anteriors; shade B1; mould CS2 | In distribution | |
| anteriors; shade C4; mould IM4 | In distribution | |
| posteriors; shade BL4; size XL; upper jaw | In distribution | |
| anteriors; shade A3; mould BL2 | In distribution | |
| anteriors; shade A3; mould BM6 | In distribution | |
| posteriors; shade D3; size L; lower jaw | In distribution | |
| anteriors; shade A3.5 light; mould CM4 | In distribution | |
| anteriors; shade A3; mould IM2 | In distribution | |
| anteriors; shade D2; mould BIS2 | In distribution | |
| anteriors; shade BL1; mould BM4 | In distribution | |
| anteriors; shade BL3; mould CM2 | In distribution | |
| anteriors; shade D2 light; mould CL2 | In distribution | |
| anteriors; shade A4; mould IM4 | In distribution | |
| posteriors; shade A4; size XL; lower jaw | In distribution | |
| anteriors; shade A3.5 light; mould UM8 | In distribution | |
| anteriors; shade D4; mould CM4 | In distribution | |
| anteriors; shade A3.5 light; mould CM6 | In distribution | |
| anteriors; shade D3; mould UM6 | In distribution | |
| anteriors; shade D2; mould IL2 | In distribution | |
| anteriors; shade C3; mould IM4 | In distribution | |
| anteriors; shade B4; mould IM6 | In distribution | |
| anteriors; shade A2 light; mould UL4 | In distribution | |
| anteriors; shade D2 light; mould UL4 | In distribution | |
| anteriors; shade A3 light; mould UM8 | In distribution | |
| anteriors; shade BL4; mould UL2 | In distribution | |
| anteriors; shade A3 light; mould IM6 | In distribution | |
| anteriors; shade D3 light; mould IM6 | In distribution | |
| anteriors; shade BL4; mould US2 | In distribution | |
| anteriors; shade A2 light; mould BM6 | In distribution | |
| anteriors; shade B3; mould BM2 | In distribution | |
| posteriors; shade C2; size S; upper jaw | In distribution | |
| anteriors; shade A1; mould BIL2 | In distribution | |
| anteriors; shade B1; mould UL2 | In distribution | |
| anteriors; shade D3; mould US4 | In distribution | |
| anteriors; shade A3.5; mould CM2 | In distribution | |
| anteriors; shade A2; mould CM6 | In distribution | |
| posteriors; shade BL3; size XL; upper jaw | In distribution | |
| anteriors; shade C4; mould BM6 | In distribution | |
| anteriors; shade C4; mould BIL2 | In distribution | |
| anteriors; shade BL4; mould BM4 | In distribution | |
| anteriors; shade A3; mould BIM4 | In distribution | |
| anteriors; shade B4; mould BIM4 | In distribution | |
| anteriors; shade A1; mould IM2 | In distribution | |
| anteriors; shade BL1; mould IM6 | In distribution | |
| anteriors; shade D3; mould BS2 | In distribution | |
| anteriors; shade A2 light; mould BS2 | In distribution | |
| anteriors; shade B1; mould BIM6 | In distribution | |
| anteriors; shade C4; mould US4 | In distribution | |
| anteriors; shade C4; mould BM2 | In distribution | |
| anteriors; shade C4; mould IM6 | In distribution | |
| anteriors; shade C2; mould CL2 | In distribution | |
| anteriors; shade D2; mould CL2 | In distribution | |
| anteriors; shade BL1; mould CL2 | In distribution | |
| posteriors; shade C2; size XL; upper jaw | In distribution | |
| anteriors; shade A4; mould BIM2 | In distribution | |
| anteriors; shade B4; mould UM8 | In distribution | |
| posteriors; shade A3 light; size L; upper jaw | In distribution | |
| anteriors; shade D2 light; mould CM6 | In distribution | |
| anteriors; shade A3; mould IL2 | In distribution | |
| anteriors; shade B1; mould BL2 | In distribution | |
| anteriors; shade B1; mould UM8 | In distribution | |
| posteriors; shade B4; size M; upper jaw | In distribution | |
| posteriors; shade BL3; size M; lower jaw | In distribution | |
| anteriors; shade C1; mould BL2 | In distribution | |
| posteriors; shade B3; size L; upper jaw | In distribution | |
| posteriors; shade BL2; size L; lower jaw | In distribution | |
| anteriors; shade A3; mould US4 | In distribution | |
| anteriors; shade A3; mould UM10 | In distribution | |
| anteriors; shade C3; mould BIM6 | In distribution | |
| anteriors; shade A3 light; mould UM2 | In distribution | |
| posteriors; shade A3.5; size XL; upper jaw | In distribution | |
| anteriors; shade C2; mould BIM6 | In distribution | |
| anteriors; shade BL1; mould BIM6 | In distribution | |
| anteriors; shade A2 light; mould UL2 | In distribution | |
| anteriors; shade C2; mould UM4 | In distribution | |
| anteriors; shade BL1; mould UM4 | In distribution | |
| anteriors; shade BL2; mould CL2 | In distribution | |
| anteriors; shade D3 light; mould UL4 | In distribution | |
| posteriors; shade A2; size XL; lower jaw | In distribution | |
| anteriors; shade D3 light; mould CM2 | In distribution |
Showing 250 of 300 catalogue numbers.
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.