Kenson
Glidewell XL Central Incisors (x2) shade 65, mould G1, U
26manufacturers in China registered for this device type
2,365catalogue 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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T1887U0L32 | In distribution | |
| T1BA3U0029 | In distribution | |
| T1287U0033 | In distribution | |
| T1AB4L0033 | In distribution | |
| T1CB1U0X34 | In distribution | |
| T1877U0S30 | In distribution | |
| T10A2L0049 | In distribution | |
| T1AA3U0031 | In distribution | |
| T1AA4U0031 | In distribution | |
| T1C61L0X34 | In distribution | |
| T1869U0031 | In distribution | |
| T1869U0033 | In distribution | |
| T1CA1L0033 | In distribution | |
| T1CA1U033M | In distribution | |
| T1865L0031 | In distribution | |
| T12D2U0031 | In distribution | |
| T1CB1U0017 | In distribution | |
| T1681U031L | In distribution | |
| T1865U0X34 | In distribution | |
| T1081U00T4 | In distribution | |
| T1GA2U00P5 | In distribution | |
| T1066L0049 | In distribution | |
| T1077U00T5 | In distribution | |
| T10D4U0015 | In distribution | |
| T1BA4L0033 | In distribution | |
| T1481L0F35 | In distribution | |
| T1G81L00G4 | In distribution | |
| T10C3U00P6 | In distribution | |
| T10C3U00T6 | In distribution | |
| T1BA4U0029 | In distribution | |
| T18B2L0031 | In distribution | |
| T1066L0053 | In distribution | |
| T1A55L0031 | In distribution | |
| T1669L031M | In distribution | |
| T10C1U0T34 | In distribution | |
| T1866U0L32 | In distribution | |
| T10B4U0029 | In distribution | |
| T14B2L0F31 | In distribution | |
| T1G65L00G2 | In distribution | |
| T14C2L0F35 | In distribution | |
| T1087U00S5 | In distribution | |
| T10D2U0T33 | In distribution | |
| T14A3U0F31 | In distribution | |
| T10C4U0T34 | In distribution | |
| T1087L0047 | In distribution | |
| T1AC4U0033 | In distribution | |
| T1BC1U0033 | In distribution | |
| T10A3L0043 | In distribution | |
| T10C2L0053 | In distribution | |
| T14B1L0F31 | In distribution | |
| T1A81L0029 | In distribution | |
| T1CA1U0033 | In distribution | |
| T1G65U00G1 | In distribution | |
| T1666L029L | In distribution | |
| T10A1U0016 | In distribution | |
| T1887U0031 | In distribution | |
| T1087U00S6 | In distribution | |
| T1681L029L | In distribution | |
| T1B66L0033 | In distribution | |
| T10A3U00T6 | In distribution | |
| T1677U031L | In distribution | |
| T1CA2U00P7 | In distribution | |
| T1081U0T34 | In distribution | |
| T1G67U00G1 | In distribution | |
| T1G61L00G2 | In distribution | |
| T10D3U00P7 | In distribution | |
| T18D3L0S30 | In distribution | |
| T18C2U0031 | In distribution | |
| T1055L0043 | In distribution | |
| T18A1U0033 | In distribution | |
| T1BA3L0031 | In distribution | |
| T1XB2U0X36 | In distribution | |
| T16A5U031L | In distribution | |
| T1A87L0033 | In distribution | |
| T1CB1L0X34 | In distribution | |
| T1062U00P5 | In distribution | |
| T1A69L0031 | In distribution | |
| T16B4U031L | In distribution | |
| T10A4L0039 | In distribution | |
| T1061U00T5 | In distribution | |
| T1081U0029 | In distribution | |
| T10C4U00T3 | In distribution | |
| T12D2L0031 | In distribution | |
| T10C1U0014 | In distribution | |
| T1CB1L0046 | In distribution | |
| T1AD4L0031 | In distribution | |
| T1AC2L0031 | In distribution | |
| T1066U00P7 | In distribution | |
| T10D4U0027 | In distribution | |
| T1069U00P7 | In distribution | |
| T10C3U0T33 | In distribution | |
| T12C1L0033 | In distribution | |
| T1B87L0031 | In distribution | |
| T10A3L0050 | In distribution | |
| T18B4U0S32 | In distribution | |
| T1061L0047 | In distribution | |
| T10A3L0039 | In distribution | |
| T10A1U0017 | In distribution | |
| T1867L0S30 | In distribution | |
| T1051U00P6 | In distribution | |
| T1466L0F31 | In distribution | |
| T1677U029M | In distribution | |
| T12A2L0029 | In distribution | |
| T18C1L0L30 | In distribution | |
| T1067L0050 | In distribution | |
| T1281U0033 | In distribution | |
| T18A3L0X34 | In distribution | |
| T1CA2L0L32 | In distribution | |
| T1867L0L32 | In distribution | |
| T1677L033M | In distribution | |
| T14C4L0F29 | In distribution | |
| T16B3U029L | In distribution | |
| T1862L0L32 | In distribution | |
| T1481L0F33 | In distribution | |
| T1851U0031 | In distribution | |
| T1069L0052 | In distribution | |
| T1069U00T4 | In distribution | |
| T1A77L0029 | In distribution | |
| T1869L0L30 | In distribution | |
| T1051L0039 | In distribution | |
| T1467L0F35 | In distribution | |
| T1666L031L | In distribution | |
| T1XC2U00XL | In distribution | |
| T10A5L0048 | In distribution | |
| T16D3U029M | In distribution | |
| T1061U00P6 | In distribution | |
| T10B1L0053 | In distribution | |
| T10D4L0049 | In distribution | |
| T1G62U00G1 | In distribution | |
| T16B3U031L | In distribution | |
| T16A3L031L | In distribution | |
| T1AC1U0031 | In distribution | |
| T1077L0050 | In distribution | |
| T10D4U00S6 | In distribution | |
| T1087U00T4 | In distribution | |
| T10C4U0028 | In distribution | |
| T16D2U029L | In distribution | |
| T1X55U0X36 | In distribution | |
| T14B1L0F35 | In distribution | |
| T1XA4U0X36 | In distribution | |
| T14B4L0F33 | In distribution | |
| T18B3L0S32 | In distribution | |
| T1061U0014 | In distribution | |
| T1665L031M | In distribution | |
| T10B1U0029 | In distribution | |
| T12C2L0033 | In distribution | |
| T1487U0F31 | In distribution | |
| T12A2L0031 | In distribution | |
| T1G67U00G3 | In distribution | |
| T1287L0033 | In distribution | |
| T1CA4L0031 | In distribution | |
| T18A5U0S32 | In distribution | |
| T1069U00T6 | In distribution | |
| T1065U0015 | In distribution | |
| T18A1U0L30 | In distribution | |
| T14A5U0F35 | In distribution | |
| T10A1L0052 | In distribution | |
| T18D2L0031 | In distribution | |
| T1G77U00G1 | In distribution | |
| T16A3U033M | In distribution | |
| T18D2U0X34 | In distribution | |
| T1066L0046 | In distribution | |
| T1081U0015 | In distribution | |
| T12C4L0033 | In distribution | |
| T1055L0049 | In distribution | |
| T10B4U00S5 | In distribution | |
| T18A3U0X34 | In distribution | |
| T1B51L0031 | In distribution | |
| T1851L0S32 | In distribution | |
| T16C1U031M | In distribution | |
| T1466L0F33 | In distribution | |
| T18B4L0S32 | In distribution | |
| T18D4U0033 | In distribution | |
| T1077L0039 | In distribution | |
| T1B55L0031 | In distribution | |
| T1CA1U0L32 | In distribution | |
| T1B77U0029 | In distribution | |
| T1051L0049 | In distribution | |
| T1XB2U00XL | In distribution | |
| T16B2U029M | In distribution | |
| T1G61U0F33 | In distribution | |
| T14A5L0F35 | In distribution | |
| T1X87U0X36 | In distribution | |
| T1262U0033 | In distribution | |
| T18B3L0033 | In distribution | |
| T1AC4L0029 | In distribution | |
| T1069U00S6 | In distribution | |
| T1065L0053 | In distribution | |
| T1662L031L | In distribution | |
| T1BA5L0031 | In distribution | |
| T1066L0050 | In distribution | |
| T1069L0043 | In distribution | |
| T10B1L0048 | In distribution | |
| T10C1U0017 | In distribution | |
| T1BB3L0033 | In distribution | |
| T1865U0033 | In distribution | |
| T10C3U0016 | In distribution | |
| T1877U0033 | In distribution | |
| T1G51U00G5 | In distribution | |
| T1881L0031 | In distribution | |
| T18A5U0X34 | In distribution | |
| T1BC3L0031 | In distribution | |
| T1051L0047 | In distribution | |
| T1461U0F33 | In distribution | |
| T18B2L0S32 | In distribution | |
| T18D2U0033 | In distribution | |
| T1881U0S30 | In distribution | |
| T10A2U00P6 | In distribution | |
| T1CA3U0015 | In distribution | |
| T16B1L031L | In distribution | |
| T1G66L00G4 | In distribution | |
| T14B3L0F31 | In distribution | |
| T1BB1L0031 | In distribution | |
| T1CA5L0049 | In distribution | |
| T14A5U0F33 | In distribution | |
| T10D2U00T5 | In distribution | |
| T1867U0X34 | In distribution | |
| T14B1U0F35 | In distribution | |
| T1865L0L32 | In distribution | |
| T1451U0F35 | In distribution | |
| T10C1L0048 | In distribution | |
| T12C2U0029 | In distribution | |
| T1661U031L | In distribution | |
| T10A2U00T3 | In distribution | |
| T1087L0053 | In distribution | |
| T12B2L0031 | In distribution | |
| T1G62U00P5 | In distribution | |
| T1CA3U00P7 | In distribution | |
| T16B3L033M | In distribution | |
| T12C2L0029 | In distribution | |
| T1B55U0029 | In distribution | |
| T16A1L029M | In distribution | |
| T10B3L0052 | In distribution | |
| T18B1U0S32 | In distribution | |
| T1B51U0033 | In distribution | |
| T10A4U0T33 | In distribution | |
| T1A87L0031 | In distribution | |
| T1B66U0031 | In distribution | |
| T1CA2U031M | In distribution | |
| T1BA1L0033 | In distribution | |
| T1066U0028 | In distribution | |
| T1G51U00G3 | In distribution | |
| T16D4L029M | In distribution | |
| T1265U0033 | In distribution | |
| T10D2U0T34 | In distribution | |
| T1055U00T4 | In distribution | |
| T1AA1U0031 | In distribution | |
| T1681L029M | In distribution | |
| T10C2U00T5 | In distribution | |
| T1051U00T5 | 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 |
| 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 |
| SR Phonares II | Ivoclar Vivadent Aktiengesellschaft | 1,441 |
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.