Myerson Standard
Anterior shade 61, mould YM5, U
26manufacturers in China registered for this device type
319catalogue numbers in this listing
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 | The Myerson Company Limited, TT |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K924526 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T6065L0007 | In distribution | |
| T600IU0YW5 | In distribution | |
| T600GU0A72 | In distribution | |
| T6061U0YM5 | In distribution | |
| T6066L0014 | In distribution | |
| T6062U0A11 | In distribution | |
| T6065L0016 | In distribution | |
| T6066L0008 | In distribution | |
| T600EU0YW3 | In distribution | |
| T6066U0A11 | In distribution | |
| T600HL0011 | In distribution | |
| T6062U0YM3 | In distribution | |
| T600IU00A4 | In distribution | |
| T600HU0A44 | In distribution | |
| T600GL0A73 | In distribution | |
| T600HL0012 | In distribution | |
| T600EL0016 | In distribution | |
| T600GU0A52 | In distribution | |
| T600IL0013 | In distribution | |
| T6065U00A2 | In distribution | |
| T600DU0A53 | In distribution | |
| T6069U0YW5 | In distribution | |
| T600DU00A7 | In distribution | |
| T6062U0A43 | In distribution | |
| T600IU0YM3 | In distribution | |
| T6065U0YW3 | In distribution | |
| T600IU00A7 | In distribution | |
| T600EU0A53 | In distribution | |
| T600HU0YW5 | In distribution | |
| T6061L0007 | In distribution | |
| T600IL0007 | In distribution | |
| T6069U00A2 | In distribution | |
| T600DU0YW5 | In distribution | |
| T6069L0012 | In distribution | |
| T600CL0017 | In distribution | |
| T600GL0A71 | In distribution | |
| T600DL0008 | In distribution | |
| T6069L0017 | In distribution | |
| T6066U0A44 | In distribution | |
| T6061L0010 | In distribution | |
| T600DU0A64 | In distribution | |
| T6069U0YW3 | In distribution | |
| T600DL0A71 | In distribution | |
| T600EL0007 | In distribution | |
| T600CL0A71 | In distribution | |
| T6062U0A64 | In distribution | |
| T6069U00A9 | In distribution | |
| T6065U0A53 | In distribution | |
| T600DL0017 | In distribution | |
| T600CL0013 | In distribution | |
| T600GL0012 | In distribution | |
| T600GL0011 | In distribution | |
| T6065U0A44 | In distribution | |
| T600IU0A72 | In distribution | |
| T600EL0010 | In distribution | |
| T600DL0012 | In distribution | |
| T600CU0A43 | In distribution | |
| T6062L0A63 | In distribution | |
| T600HL0010 | In distribution | |
| T600GU00A9 | In distribution | |
| T6065L0A73 | In distribution | |
| T600EL0014 | In distribution | |
| T600HU00A4 | In distribution | |
| T6062U00A9 | In distribution | |
| T6065L0003 | In distribution | |
| T6066L0012 | In distribution | |
| T600DU0YM5 | In distribution | |
| T600CU0A52 | In distribution | |
| T600GU0A64 | In distribution | |
| T600IU0A52 | In distribution | |
| T600DU00A9 | In distribution | |
| T6062U0YW3 | In distribution | |
| T6066U00A2 | In distribution | |
| T6062U00A4 | In distribution | |
| T6062L0007 | In distribution | |
| T600EU00A7 | In distribution | |
| T6065L0010 | In distribution | |
| T6066L0011 | In distribution | |
| T600CL0010 | In distribution | |
| T6065U0YW5 | In distribution | |
| T6069L0014 | In distribution | |
| T600DU0A13 | In distribution | |
| T6062U0A53 | In distribution | |
| T600GU0A11 | In distribution | |
| T600HU0A11 | In distribution | |
| T600CU0A11 | In distribution | |
| T600GU0A43 | In distribution | |
| T6065L0012 | In distribution | |
| T600IU0A53 | In distribution | |
| T600HL0A73 | In distribution | |
| T6065U0A13 | In distribution | |
| T6062L0A71 | In distribution | |
| T600EU0YM3 | In distribution | |
| T600EL0A73 | In distribution | |
| T6065U0A11 | In distribution | |
| T600HL0014 | In distribution | |
| T6066L0003 | In distribution | |
| T6065U0YM5 | In distribution | |
| T6065L0008 | In distribution | |
| T600GU0A13 | In distribution | |
| T600GL0007 | In distribution | |
| T6066L0A71 | In distribution | |
| T6066U0A13 | In distribution | |
| T600EU00A4 | In distribution | |
| T6061L0011 | In distribution | |
| T6066L0013 | In distribution | |
| T600DU0A72 | In distribution | |
| T600EU0YW5 | In distribution | |
| T600HU0A72 | In distribution | |
| T600GU0A44 | In distribution | |
| T600GL0010 | In distribution | |
| T6061L0012 | In distribution | |
| T6069U0A11 | In distribution | |
| T600DL0A63 | In distribution | |
| T600DU0A52 | In distribution | |
| T6069U0YM5 | In distribution | |
| T6069U0A52 | In distribution | |
| T600EL0A63 | In distribution | |
| T600CL0016 | In distribution | |
| T600IL0A63 | In distribution | |
| T600DL0A73 | In distribution | |
| T600CU00A7 | In distribution | |
| T600EU0A44 | In distribution | |
| T6065U0A43 | In distribution | |
| T600HL0A71 | In distribution | |
| T600IL0A73 | In distribution | |
| T6066L0007 | In distribution | |
| T600HU00A9 | In distribution | |
| T6065L0A63 | In distribution | |
| T600IU0A13 | In distribution | |
| T6065L0013 | In distribution | |
| T6069U0A43 | In distribution | |
| T600GL0008 | In distribution | |
| T600HL0013 | In distribution | |
| T600HU0YM3 | In distribution | |
| T6069L0003 | In distribution | |
| T600HL0007 | In distribution | |
| T6065L0014 | In distribution | |
| T6069L0010 | In distribution | |
| T600HL0008 | In distribution | |
| T600IU0A44 | In distribution | |
| T600EL0008 | In distribution | |
| T6062L0003 | In distribution | |
| T600EU00A9 | In distribution | |
| T6061L0008 | In distribution | |
| T600CU0A64 | In distribution | |
| T6061U0A64 | In distribution | |
| T6066U0YM3 | In distribution | |
| T600IU0A43 | In distribution | |
| T600CL0A63 | In distribution | |
| T6065U00A9 | In distribution | |
| T600IU00A2 | In distribution | |
| T6066U00A9 | In distribution | |
| T6066L0016 | In distribution | |
| T6069L0A73 | In distribution | |
| T6061L0A63 | In distribution | |
| T6066L0A73 | In distribution | |
| T600HL0016 | In distribution | |
| T600IL0012 | In distribution | |
| T600DL0014 | In distribution | |
| T6069U0A44 | In distribution | |
| T6062L0010 | In distribution | |
| T600HL0003 | In distribution | |
| T6069L0016 | In distribution | |
| T6062U00A7 | In distribution | |
| T6069L0011 | In distribution | |
| T6062L0011 | In distribution | |
| T600GL0A63 | In distribution | |
| T600DL0007 | In distribution | |
| T6062L0012 | In distribution | |
| T6066L0010 | In distribution | |
| T6061L0003 | In distribution | |
| T600CU0A44 | In distribution | |
| T6062U0A44 | In distribution | |
| T6061U0A53 | In distribution | |
| T600DL0011 | In distribution | |
| T6061U0YM3 | In distribution | |
| T600IU0A64 | In distribution | |
| T600GL0013 | In distribution | |
| T600IL0011 | In distribution | |
| T6066U0A53 | In distribution | |
| T600IU0YM5 | In distribution | |
| T600GL0014 | In distribution | |
| T6066L0017 | In distribution | |
| T600EL0A71 | In distribution | |
| T600DL0013 | In distribution | |
| T600DU00A4 | In distribution | |
| T600CL0014 | In distribution | |
| T6062U00A2 | In distribution | |
| T6069U00A7 | In distribution | |
| T6062U0YW5 | In distribution | |
| T6061U0A72 | In distribution | |
| T600EU0A11 | In distribution | |
| T600DU0A44 | In distribution | |
| T6062U0A52 | In distribution | |
| T600EU0YM5 | In distribution | |
| T600GU0YW3 | In distribution | |
| T600DL0016 | In distribution | |
| T600HL0A63 | In distribution | |
| T600GL0003 | In distribution | |
| T6061U0A11 | In distribution | |
| T6066U0A43 | In distribution | |
| T6069L0008 | In distribution | |
| T600CU00A4 | In distribution | |
| T600HU0A52 | In distribution | |
| T600EL0013 | In distribution | |
| T6061U00A2 | In distribution | |
| T6066U00A7 | In distribution | |
| T6061U0YW3 | In distribution | |
| T600IU0YW3 | In distribution | |
| T600IU00A9 | In distribution | |
| T6069L0A71 | In distribution | |
| T600EU0A52 | In distribution | |
| T600EL0003 | In distribution | |
| T6062L0A73 | In distribution | |
| T600CL0011 | In distribution | |
| T600GU0YW5 | In distribution | |
| T600GU00A4 | In distribution | |
| T600CU0A72 | In distribution | |
| T600GU0YM5 | In distribution | |
| T6061L0A71 | In distribution | |
| T6061U00A7 | In distribution | |
| T600GU0YM3 | In distribution | |
| T600CU0YM3 | In distribution | |
| T600GU00A7 | In distribution | |
| T6069U0A13 | In distribution | |
| T600CU0YW5 | In distribution | |
| T600HU0YM5 | In distribution | |
| T600HU00A2 | In distribution | |
| T600CU0A13 | In distribution | |
| T6061U0A52 | In distribution | |
| T6069U0A53 | In distribution | |
| T6069U0A72 | In distribution | |
| T600HU0A64 | In distribution | |
| T6065L0A71 | In distribution | |
| T600HU0A43 | In distribution | |
| T6061U0A13 | In distribution | |
| T600DU0A43 | In distribution | |
| T6069U0YM3 | In distribution | |
| T600IL0016 | In distribution | |
| T600DL0010 | In distribution | |
| T6062L0014 | In distribution | |
| T600CL0007 | In distribution | |
| T6061L0017 | In distribution | |
| T6062U0YM5 | In distribution | |
| T6062L0017 | In distribution | |
| T6065U00A4 | In distribution | |
| T600CL0012 | In distribution | |
| T600CU00A2 | In distribution | |
| T600IL0010 | 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
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.