Myerson Lingualized Integration
Posterior shade A3.5, mould CC, L
26manufacturers in China registered for this device type
64catalogue 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 |
|---|---|---|
| T42C2U00CC | In distribution | |
| T42A4U00CC | In distribution | |
| T42A5L00CC | In distribution | |
| T42D4L00MC | In distribution | |
| T42C1L00MC | In distribution | |
| T42D4U00MC | In distribution | |
| T42D2U00CC | In distribution | |
| T42A5L00MC | In distribution | |
| T42C3U00MC | In distribution | |
| T42C1U00CC | In distribution | |
| T42A3L00MC | In distribution | |
| T42B4L00MC | In distribution | |
| T42B1L00MC | In distribution | |
| T42A1U00MC | In distribution | |
| T42D3L00MC | In distribution | |
| T42A4L00MC | In distribution | |
| T42A5U00CC | In distribution | |
| T42C3L00CC | In distribution | |
| T42A5U00MC | In distribution | |
| T42B4L00CC | In distribution | |
| T42B3U00CC | In distribution | |
| T42A3L00CC | In distribution | |
| T42C4L00CC | In distribution | |
| T42C4L00MC | In distribution | |
| T42A1L00MC | In distribution | |
| T42A2L00MC | In distribution | |
| T42A1U00CC | In distribution | |
| T42D4L00CC | In distribution | |
| T42C2U00MC | In distribution | |
| T42C2L00MC | In distribution | |
| T42C1U00MC | In distribution | |
| T42A3U00MC | In distribution | |
| T42B2L00CC | In distribution | |
| T42D3L00CC | In distribution | |
| T42B3L00CC | In distribution | |
| T42C2L00CC | In distribution | |
| T42C3U00CC | In distribution | |
| T42B1U00CC | In distribution | |
| T42B4U00CC | In distribution | |
| T42A1L00CC | In distribution | |
| T42A2U00MC | In distribution | |
| T42B2L00MC | In distribution | |
| T42B2U00MC | In distribution | |
| T42A2L00CC | In distribution | |
| T42C3L00MC | In distribution | |
| T42D2U00MC | In distribution | |
| T42B3L00MC | In distribution | |
| T42C4U00MC | In distribution | |
| T42B1L00CC | In distribution | |
| T42B2U00CC | In distribution | |
| T42D3U00MC | In distribution | |
| T42D3U00CC | In distribution | |
| T42C1L00CC | In distribution | |
| T42A4L00CC | In distribution | |
| T42C4U00CC | In distribution | |
| T42D2L00MC | In distribution | |
| T42A3U00CC | In distribution | |
| T42A2U00CC | In distribution | |
| T42A4U00MC | In distribution | |
| T42D4U00CC | In distribution | |
| T42B1U00MC | In distribution | |
| T42B3U00MC | In distribution | |
| T42D2L00CC | In distribution | |
| T42B4U00MC | 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.