Myerson MLI
Anterior shade A3.5, mould M13, U
26manufacturers in China registered for this device type
160catalogue 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 |
|---|---|---|
| T40D3U00M1 | In distribution | |
| T40B2U00M9 | In distribution | |
| T40A5U00M1 | In distribution | |
| T40B2U0M13 | In distribution | |
| T40C2L00M2 | In distribution | |
| T40A3L00M2 | In distribution | |
| T40A2U00M5 | In distribution | |
| T40B3L00M2 | In distribution | |
| T40A5U00M5 | In distribution | |
| T40C3U00M1 | In distribution | |
| T40D2U00M3 | In distribution | |
| T40C2U00M5 | In distribution | |
| T40D4U00M7 | In distribution | |
| T40D3U00M9 | In distribution | |
| T40A2L00M4 | In distribution | |
| T40A3U00M7 | In distribution | |
| T40D2U0M13 | In distribution | |
| T40A2L00M6 | In distribution | |
| T40C1L00M6 | In distribution | |
| T40D2U0M11 | In distribution | |
| T40B4U0M13 | In distribution | |
| T40B2U00M1 | In distribution | |
| T40A4L00M6 | In distribution | |
| T40C3L00M4 | In distribution | |
| T40A3L00M4 | In distribution | |
| T40C3L00M2 | In distribution | |
| T40D2U00M9 | In distribution | |
| T40A1U0M11 | In distribution | |
| T40D3L00M4 | In distribution | |
| T40C4U00M7 | In distribution | |
| T40D4L00M6 | In distribution | |
| T40A1L00M6 | In distribution | |
| T40B2U00M7 | In distribution | |
| T40D4U00M5 | In distribution | |
| T40D2L00M6 | In distribution | |
| T40A1U00M5 | In distribution | |
| T40B1U00M5 | In distribution | |
| T40D4L00M2 | In distribution | |
| T40B4U0M11 | In distribution | |
| T40D3U00M5 | In distribution | |
| T40C2L00M4 | In distribution | |
| T40A2U00M9 | In distribution | |
| T40B4U00M3 | In distribution | |
| T40A4U00M1 | In distribution | |
| T40A1L00M2 | In distribution | |
| T40C1U0M11 | In distribution | |
| T40A3U00M5 | In distribution | |
| T40C1U00M3 | In distribution | |
| T40D4U00M3 | In distribution | |
| T40B1L00M6 | In distribution | |
| T40B3U00M5 | In distribution | |
| T40C3U0M13 | In distribution | |
| T40C1L00M2 | In distribution | |
| T40B4L00M2 | In distribution | |
| T40C2U00M9 | In distribution | |
| T40C2U00M3 | In distribution | |
| T40C4L00M4 | In distribution | |
| T40A4U00M5 | In distribution | |
| T40D2L00M4 | In distribution | |
| T40B3U00M1 | In distribution | |
| T40C1U00M5 | In distribution | |
| T40B2L00M2 | In distribution | |
| T40B1U00M3 | In distribution | |
| T40D3U0M13 | In distribution | |
| T40B2L00M6 | In distribution | |
| T40A5L00M4 | In distribution | |
| T40A2L00M2 | In distribution | |
| T40C2U0M13 | In distribution | |
| T40B1U00M1 | In distribution | |
| T40B1U00M7 | In distribution | |
| T40A5U00M7 | In distribution | |
| T40A5U00M3 | In distribution | |
| T40C3U00M7 | In distribution | |
| T40D4U0M11 | In distribution | |
| T40C1U00M7 | In distribution | |
| T40D3U00M3 | In distribution | |
| T40C1U0M13 | In distribution | |
| T40B4U00M9 | In distribution | |
| T40B2U00M5 | In distribution | |
| T40B1U0M13 | In distribution | |
| T40B2U00M3 | In distribution | |
| T40C1U00M9 | In distribution | |
| T40C3L00M6 | In distribution | |
| T40A2U0M13 | In distribution | |
| T40B1L00M2 | In distribution | |
| T40B4U00M7 | In distribution | |
| T40B3L00M6 | In distribution | |
| T40A5U00M9 | In distribution | |
| T40A1U00M1 | In distribution | |
| T40A3U00M9 | In distribution | |
| T40A2U00M1 | In distribution | |
| T40A5L00M2 | In distribution | |
| T40B4U00M5 | In distribution | |
| T40A3U00M3 | In distribution | |
| T40C4U0M13 | In distribution | |
| T40C4U0M11 | In distribution | |
| T40C4L00M6 | In distribution | |
| T40C3U00M9 | In distribution | |
| T40D3L00M6 | In distribution | |
| T40B3U00M9 | In distribution | |
| T40B3U00M3 | In distribution | |
| T40B1U0M11 | In distribution | |
| T40B4L00M4 | In distribution | |
| T40D2L00M2 | In distribution | |
| T40A4U0M13 | In distribution | |
| T40B3U00M7 | In distribution | |
| T40A4L00M2 | In distribution | |
| T40B1U00M9 | In distribution | |
| T40D4U00M9 | In distribution | |
| T40A1U00M9 | In distribution | |
| T40C4U00M1 | In distribution | |
| T40A1U00M3 | In distribution | |
| T40A3U0M11 | In distribution | |
| T40A4U00M9 | In distribution | |
| T40C3U0M11 | In distribution | |
| T40D2U00M5 | In distribution | |
| T40A5U0M13 | In distribution | |
| T40D4U00M1 | In distribution | |
| T40A4U00M3 | In distribution | |
| T40D2U00M1 | In distribution | |
| T40A4L00M4 | In distribution | |
| T40C2L00M6 | In distribution | |
| T40C3U00M3 | In distribution | |
| T40D3U0M11 | In distribution | |
| T40C3U00M5 | In distribution | |
| T40B3U0M11 | In distribution | |
| T40C4U00M3 | In distribution | |
| T40A1U0M13 | In distribution | |
| T40C1U00M1 | In distribution | |
| T40B4L00M6 | In distribution | |
| T40A5U0M11 | In distribution | |
| T40C4U00M9 | In distribution | |
| T40A3U0M13 | In distribution | |
| T40B3U0M13 | In distribution | |
| T40D3U00M7 | In distribution | |
| T40A1L00M4 | In distribution | |
| T40A1U00M7 | In distribution | |
| T40B1L00M4 | In distribution | |
| T40A3L00M6 | In distribution | |
| T40A2U00M3 | In distribution | |
| T40C2U00M1 | In distribution | |
| T40D4L00M4 | In distribution | |
| T40A4U00M7 | In distribution | |
| T40B2U0M11 | In distribution | |
| T40A2U00M7 | In distribution | |
| T40D2U00M7 | In distribution | |
| T40B3L00M4 | In distribution | |
| T40C1L00M4 | In distribution | |
| T40A5L00M6 | In distribution | |
| T40B4U00M1 | In distribution | |
| T40D4U0M13 | In distribution | |
| T40C4L00M2 | In distribution | |
| T40C2U00M7 | In distribution | |
| T40A2U0M11 | In distribution | |
| T40C2U0M11 | In distribution | |
| T40A4U0M11 | In distribution | |
| T40C4U00M5 | In distribution | |
| T40B2L00M4 | In distribution | |
| T40D3L00M2 | In distribution | |
| T40A3U00M1 | 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
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.