Polystar HK
Living mould chart Polystar HK in shade A3 containing: 30 upper and 15 lower anterior sets, 9 upper and 9 lower posterior sets
26manufacturers in China registered for this device type
1,009catalogue 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 | 2017-01-21 |
| 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 |
|---|---|---|
| posteriors; shade D4; size 4; upper jaw | In distribution | |
| posteriors; shade B2; size 30; upper jaw | In distribution | |
| anteriors; shade C3; mould R 47 | In distribution | |
| anteriors; shade A3.5; mould 91 | In distribution | |
| posteriors; shade B1; size 3 S; lower jaw | In distribution | |
| posteriors; shade C2; size 2; upper jaw | In distribution | |
| anteriors; shade A4; mould R 89 | In distribution | |
| anteriors; shade B1; mould O 85 | In distribution | |
| anteriors; shade A3; mould R 69 | In distribution | |
| posteriors; shade A1; size 3; lower jaw | In distribution | |
| anteriors; shade A3.5; mould 99 | In distribution | |
| anteriors; shade B4; mould O 48 | In distribution | |
| anteriors; shade B1; mould O 52 | In distribution | |
| posteriors; shade C3; size 6; lower jaw | In distribution | |
| posteriors; shade A1; size 2; upper jaw | In distribution | |
| anteriors; shade A1; mould Q 84 | In distribution | |
| anteriors; shade C3; mould D 68 | In distribution | |
| anteriors; shade B2; mould Q 46 | In distribution | |
| anteriors; shade B3; mould 95 | In distribution | |
| posteriors; shade B3; size 6; upper jaw | In distribution | |
| anteriors; shade B1; mould 96 | In distribution | |
| anteriors; shade C1; mould Q 77 | In distribution | |
| anteriors; shade C2; mould 101 | In distribution | |
| anteriors; shade A1; mould 91 | In distribution | |
| anteriors; shade C1; mould Q 63 | In distribution | |
| anteriors; shade A3; mould R 66 | In distribution | |
| anteriors; shade C1; mould D 68 | In distribution | |
| posteriors; shade A3; size 3 S; lower jaw | In distribution | |
| anteriors; shade D2; mould R 66 | In distribution | |
| anteriors; shade A2; mould R 88 | In distribution | |
| posteriors; shade A1; size 60; lower jaw | In distribution | |
| posteriors; shade C2; size 3; lower jaw | In distribution | |
| anteriors; shade A3; mould 99 | In distribution | |
| anteriors; shade B2; mould Q 62 | In distribution | |
| anteriors; shade A3.5; mould 92 S | In distribution | |
| posteriors; shade C2; size 60; lower jaw | In distribution | |
| anteriors; shade D2; mould R 89 | In distribution | |
| anteriors; shade C4; mould Q 84 | In distribution | |
| anteriors; shade B1; mould R 49 | In distribution | |
| anteriors; shade A1; mould Q 58 | In distribution | |
| anteriors; shade A3; mould R 60 | In distribution | |
| anteriors; shade A3.5; mould Q 45 | In distribution | |
| anteriors; shade C3; mould 100 | In distribution | |
| posteriors; shade B1; size 4; upper jaw | In distribution | |
| posteriors; shade C1; size 50; lower jaw | In distribution | |
| anteriors; shade C4; mould R 60 | In distribution | |
| posteriors; shade C4; size 4; upper jaw | In distribution | |
| anteriors; shade A4; mould D 82 | In distribution | |
| anteriors; shade D3; mould R 75 | In distribution | |
| anteriors; shade B4; mould D 82 | In distribution | |
| anteriors; shade C2; mould D 65 | In distribution | |
| anteriors; shade D2; mould 98 | In distribution | |
| anteriors; shade A1; mould R 47 | In distribution | |
| anteriors; shade B2; mould Q 58 | In distribution | |
| anteriors; shade A2; mould 101 | In distribution | |
| anteriors; shade D2; mould R 47 | In distribution | |
| anteriors; shade A3.5; mould Q 46 | In distribution | |
| posteriors; shade C1; size 6; upper jaw | In distribution | |
| anteriors; shade A3.5; mould 100 | In distribution | |
| anteriors; shade C3; mould 92 | In distribution | |
| posteriors; shade C2; size 3; upper jaw | In distribution | |
| anteriors; shade B1; mould Q 46 | In distribution | |
| anteriors; shade C2; mould Q 84 | In distribution | |
| posteriors; shade A1; size 30; lower jaw | In distribution | |
| anteriors; shade C3; mould O 48 | In distribution | |
| anteriors; shade D4; mould R 47 | In distribution | |
| posteriors; shade C1; size 40; upper jaw | In distribution | |
| anteriors; shade A4; mould D 67 | In distribution | |
| anteriors; shade D2; mould Q 64 | In distribution | |
| posteriors; shade D4; size 2; upper jaw | In distribution | |
| anteriors; shade C4; mould 94 | In distribution | |
| anteriors; shade C1; mould Q 78 | In distribution | |
| posteriors; shade C3; size 30; upper jaw | In distribution | |
| anteriors; shade B2; mould 93 S | In distribution | |
| anteriors; shade B1; mould Q 78 | In distribution | |
| posteriors; shade A3.5; size 60; upper jaw | In distribution | |
| anteriors; shade B3; mould R 88 | In distribution | |
| anteriors; shade C3; mould Q 62 | In distribution | |
| posteriors; shade C3; size 6; upper jaw | In distribution | |
| posteriors; shade B1; size 6; upper jaw | In distribution | |
| posteriors; shade C1; size 60; lower jaw | In distribution | |
| posteriors; shade C3; size 40; lower jaw | In distribution | |
| anteriors; shade B4; mould R 69 | In distribution | |
| anteriors; shade B2; mould O 85 | In distribution | |
| posteriors; shade D2; size 50; upper jaw | In distribution | |
| anteriors; shade B4; mould R 86 | In distribution | |
| posteriors; shade A4; size 50; lower jaw | In distribution | |
| anteriors; shade C4; mould 91 | In distribution | |
| posteriors; shade A2; size 6; upper jaw | In distribution | |
| posteriors; shade D3; size 50; upper jaw | In distribution | |
| anteriors; shade A2; mould 92 | In distribution | |
| posteriors; shade C3; size 50; lower jaw | In distribution | |
| anteriors; shade A3.5; mould Q 78 | In distribution | |
| anteriors; shade B3; mould O 48 | In distribution | |
| anteriors; shade B3; mould R 76 | In distribution | |
| posteriors; shade C4; size 3 S; lower jaw | In distribution | |
| anteriors; shade C1; mould D 67 | In distribution | |
| posteriors; shade B2; size 40; lower jaw | In distribution | |
| anteriors; shade A3.5; mould 95 | In distribution | |
| anteriors; shade A1; mould O 52 | In distribution | |
| posteriors; shade D2; size 40; lower jaw | In distribution | |
| posteriors; shade A1; size 6; lower jaw | In distribution | |
| anteriors; shade A4; mould Q 58 | In distribution | |
| anteriors; shade B1; mould Q 45 | In distribution | |
| posteriors; shade A1; size 4; lower jaw | In distribution | |
| posteriors; shade C1; size 30; lower jaw | In distribution | |
| anteriors; shade A4; mould 101 | In distribution | |
| anteriors; shade B2; mould 93 | In distribution | |
| posteriors; shade C4; size 3; upper jaw | In distribution | |
| anteriors; shade C4; mould Q 63 | In distribution | |
| anteriors; shade D3; mould 92 S | In distribution | |
| posteriors; shade A3; size 6; lower jaw | In distribution | |
| posteriors; shade C2; size 4; lower jaw | In distribution | |
| anteriors; shade C4; mould Q 77 | In distribution | |
| anteriors; shade B4; mould O 52 | In distribution | |
| posteriors; shade C4; size 40; lower jaw | In distribution | |
| posteriors; shade B3; size 40; upper jaw | In distribution | |
| anteriors; shade A2; mould Q 78 | In distribution | |
| anteriors; shade C3; mould R 75 | In distribution | |
| anteriors; shade D4; mould R 51 | In distribution | |
| anteriors; shade B3; mould Q 77 | In distribution | |
| posteriors; shade C3; size 3; upper jaw | In distribution | |
| anteriors; shade A2; mould R 60 | In distribution | |
| anteriors; shade A4; mould D 68 | In distribution | |
| anteriors; shade C1; mould 93 | In distribution | |
| posteriors; shade D2; size 3 S; upper jaw | In distribution | |
| anteriors; shade A3; mould 96 | In distribution | |
| anteriors; shade A4; mould R 47 | In distribution | |
| posteriors; shade D4; size 3 S; lower jaw | In distribution | |
| posteriors; shade A3; size 3; upper jaw | In distribution | |
| anteriors; shade A4; mould R 66 | In distribution | |
| anteriors; shade B4; mould D 65 | In distribution | |
| anteriors; shade A4; mould R 87 | In distribution | |
| anteriors; shade D3; mould 96 | In distribution | |
| anteriors; shade A2; mould 94 | In distribution | |
| anteriors; shade B3; mould R 60 | In distribution | |
| anteriors; shade D3; mould R 86 | In distribution | |
| anteriors; shade B3; mould D 82 | In distribution | |
| anteriors; shade D3; mould R 66 | In distribution | |
| anteriors; shade C3; mould 97 | In distribution | |
| posteriors; shade B4; size 30; upper jaw | In distribution | |
| anteriors; shade A3; mould R 88 | In distribution | |
| anteriors; shade A2; mould Q 58 | In distribution | |
| anteriors; shade A4; mould 93 S | In distribution | |
| anteriors; shade B1; mould 92 S | In distribution | |
| anteriors; shade D4; mould 90 | In distribution | |
| posteriors; shade D2; size 30; upper jaw | In distribution | |
| anteriors; shade A4; mould Q 77 | In distribution | |
| anteriors; shade C2; mould R 86 | In distribution | |
| anteriors; shade D3; mould Q 58 | In distribution | |
| anteriors; shade C4; mould 96 | In distribution | |
| anteriors; shade D3; mould R 89 | In distribution | |
| anteriors; shade D2; mould 90 | In distribution | |
| anteriors; shade B2; mould 92 S | In distribution | |
| anteriors; shade D2; mould 95 | In distribution | |
| posteriors; shade D2; size 6; upper jaw | In distribution | |
| anteriors; shade D2; mould R 88 | In distribution | |
| anteriors; shade A4; mould Q 64 | In distribution | |
| posteriors; shade B3; size 30; upper jaw | In distribution | |
| anteriors; shade A3; mould Q 45 | In distribution | |
| anteriors; shade B3; mould R 75 | In distribution | |
| anteriors; shade A1; mould 100 | In distribution | |
| anteriors; shade A4; mould Q 84 | In distribution | |
| posteriors; shade B4; size 60; upper jaw | In distribution | |
| anteriors; shade C2; mould R 47 | In distribution | |
| anteriors; shade B1; mould 99 | In distribution | |
| anteriors; shade C1; mould Q 83 | In distribution | |
| posteriors; shade A3; size 40; upper jaw | In distribution | |
| anteriors; shade D3; mould 101 | In distribution | |
| anteriors; shade C4; mould R 89 | In distribution | |
| posteriors; shade C2; size 6; lower jaw | In distribution | |
| anteriors; shade B1; mould Q 58 | In distribution | |
| anteriors; shade B2; mould 102 | In distribution | |
| posteriors; shade A4; size 40; upper jaw | In distribution | |
| anteriors; shade B2; mould 95 | In distribution | |
| anteriors; shade A2; mould O 48 | In distribution | |
| anteriors; shade B2; mould R 60 | In distribution | |
| anteriors; shade A4; mould O 85 | In distribution | |
| anteriors; shade D2; mould 93 | In distribution | |
| posteriors; shade A4; size 3 S; lower jaw | In distribution | |
| anteriors; shade A2; mould 98 | In distribution | |
| anteriors; shade A2; mould Q 84 | In distribution | |
| anteriors; shade A4; mould 102 | In distribution | |
| anteriors; shade D3; mould Q 77 | In distribution | |
| posteriors; shade A2; size 3; upper jaw | In distribution | |
| anteriors; shade A2; mould 99 | In distribution | |
| posteriors; shade B3; size 50; lower jaw | In distribution | |
| anteriors; shade C2; mould 99 | In distribution | |
| posteriors; shade C2; size 40; upper jaw | In distribution | |
| anteriors; shade D2; mould O 85 | In distribution | |
| anteriors; shade A1; mould 90 | In distribution | |
| anteriors; shade A1; mould D 82 | In distribution | |
| anteriors; shade C2; mould D 67 | In distribution | |
| anteriors; shade D2; mould Q 62 | In distribution | |
| anteriors; shade B4; mould 91 | In distribution | |
| anteriors; shade C1; mould 91 | In distribution | |
| anteriors; shade B1; mould 100 | In distribution | |
| anteriors; shade C1; mould R 75 | In distribution | |
| anteriors; shade C1; mould R 76 | In distribution | |
| posteriors; shade D3; size 2; upper jaw | In distribution | |
| anteriors; shade D2; mould O 48 | In distribution | |
| posteriors; shade A1; size 50; upper jaw | In distribution | |
| anteriors; shade B4; mould Q 84 | In distribution | |
| anteriors; shade D2; mould 100 | In distribution | |
| anteriors; shade D2; mould Q 46 | In distribution | |
| posteriors; shade B4; size 2; upper jaw | In distribution | |
| anteriors; shade A4; mould Q 83 | In distribution | |
| posteriors; shade A2; size 30; upper jaw | In distribution | |
| posteriors; shade B2; size 2; lower jaw | In distribution | |
| anteriors; shade D2; mould Q 58 | In distribution | |
| anteriors; shade C2; mould 90 | In distribution | |
| posteriors; shade C2; size 2; lower jaw | In distribution | |
| anteriors; shade D3; mould R 51 | In distribution | |
| anteriors; shade C2; mould R 51 | In distribution | |
| posteriors; shade D3; size 60; lower jaw | In distribution | |
| anteriors; shade D4; mould R 55 | In distribution | |
| anteriors; shade D3; mould R 87 | In distribution | |
| anteriors; shade A3.5; mould Q 84 | In distribution | |
| anteriors; shade A3; mould D 68 | In distribution | |
| anteriors; shade B4; mould 97 | In distribution | |
| posteriors; shade A3.5; size 3 S; upper jaw | In distribution | |
| anteriors; shade C1; mould R 86 | In distribution | |
| anteriors; shade D2; mould R 75 | In distribution | |
| posteriors; shade B3; size 60; upper jaw | In distribution | |
| anteriors; shade A3; mould Q 63 | In distribution | |
| anteriors; shade B3; mould Q 62 | In distribution | |
| anteriors; shade A2; mould 93 S | In distribution | |
| anteriors; shade C4; mould 90 | In distribution | |
| posteriors; shade D3; size 40; upper jaw | In distribution | |
| anteriors; shade C3; mould R 66 | In distribution | |
| anteriors; shade B4; mould Q 77 | In distribution | |
| posteriors; shade A3.5; size 3; lower jaw | In distribution | |
| posteriors; shade A1; size 30; upper jaw | In distribution | |
| posteriors; shade A3.5; size 60; lower jaw | In distribution | |
| anteriors; shade B4; mould Q 63 | In distribution | |
| posteriors; shade A4; size 2; upper jaw | In distribution | |
| anteriors; shade B3; mould O 85 | In distribution | |
| anteriors; shade B4; mould Q 58 | In distribution | |
| posteriors; shade C2; size 40; lower jaw | In distribution | |
| posteriors; shade D3; size 3 S; lower jaw | In distribution | |
| anteriors; shade A3.5; mould R 89 | In distribution | |
| anteriors; shade B3; mould Q 63 | In distribution | |
| anteriors; shade C1; mould R 47 | In distribution | |
| anteriors; shade B2; mould 97 | In distribution | |
| anteriors; shade B1; mould R 87 | In distribution | |
| anteriors; shade A3.5; mould Q 77 | In distribution | |
| posteriors; shade A4; size 60; upper jaw | In distribution | |
| anteriors; shade D4; mould Q 78 | In distribution | |
| anteriors; shade A3.5; mould 96 | In distribution | |
| anteriors; shade A1; mould 102 | 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.