Swissedent Hdc
20° Posterior shade A3.5, mould 25SL, L
26manufacturers in China registered for this device type
848catalogue 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 |
|---|---|---|
| T80D3U0453 | In distribution | |
| T80C1L0083 | In distribution | |
| T80A1U0233 | In distribution | |
| T80A5L0052 | In distribution | |
| T80B2U0234 | In distribution | |
| T80C2U0212 | In distribution | |
| T80D3L0081 | In distribution | |
| T80A3U0343 | In distribution | |
| T80B1U0263 | In distribution | |
| T80A4U0424 | In distribution | |
| T80D3U0263 | In distribution | |
| T82D3L026L | In distribution | |
| T80C4U0332 | In distribution | |
| T82D2L022L | In distribution | |
| T84B2L035L | In distribution | |
| T84C1U035U | In distribution | |
| T80A2U0232 | In distribution | |
| T84D4L036L | In distribution | |
| T80C4U0232 | In distribution | |
| T80B4U0413 | In distribution | |
| T80C1U0343 | In distribution | |
| T80A4U0304 | In distribution | |
| T80B1U0453 | In distribution | |
| T80A3U0413 | In distribution | |
| T82C2U025U | In distribution | |
| T80A4L0052 | In distribution | |
| T80B2U0213 | In distribution | |
| T80B3U0202 | In distribution | |
| T80C1U0332 | In distribution | |
| T80A5U0202 | In distribution | |
| T84D2U035U | In distribution | |
| T84B1U032U | In distribution | |
| T84C2U035U | In distribution | |
| T80A3L0053 | In distribution | |
| T84C4U038U | In distribution | |
| T84A2U038U | In distribution | |
| T80C2U0302 | In distribution | |
| T80C1U0425 | In distribution | |
| T82A3L025L | In distribution | |
| T80D4U0423 | In distribution | |
| T80C3U0403 | In distribution | |
| T82D2L25SL | In distribution | |
| T80B3U0233 | In distribution | |
| T80C1U0403 | In distribution | |
| T80A3U0233 | In distribution | |
| T80A3U0232 | In distribution | |
| T80D3U0424 | In distribution | |
| T80B4U0352 | In distribution | |
| T80C4U0352 | In distribution | |
| T84A5U032U | In distribution | |
| T82C1U022U | In distribution | |
| T80C1U0213 | In distribution | |
| T80B1L0082 | In distribution | |
| T80B2U0452 | In distribution | |
| T80C2U0343 | In distribution | |
| T80C4L0082 | In distribution | |
| T80C4L0081 | In distribution | |
| T80C4L0080 | In distribution | |
| T80C3U0423 | In distribution | |
| T80A5U0232 | In distribution | |
| T80A1U0224 | In distribution | |
| T80B1U0213 | In distribution | |
| T80C4U0412 | In distribution | |
| T80A3U0424 | In distribution | |
| T80C1U0424 | In distribution | |
| T80D3U0343 | In distribution | |
| T82A4U25SU | In distribution | |
| T84B1L032L | In distribution | |
| T80A5U0302 | In distribution | |
| T80B1U0425 | In distribution | |
| T80A2U0213 | In distribution | |
| T80D3U0264 | In distribution | |
| T84C4L036L | In distribution | |
| T80B2U0304 | In distribution | |
| T84D3U032U | In distribution | |
| T80A1U0303 | In distribution | |
| T80C2U0412 | In distribution | |
| T80D2U0333 | In distribution | |
| T80D3U0304 | In distribution | |
| T80A2U0403 | In distribution | |
| T82C3L25SL | In distribution | |
| T80A4U0412 | In distribution | |
| T80C2U0452 | In distribution | |
| T84A5L035L | In distribution | |
| T80B3U0412 | In distribution | |
| T82A1L026L | In distribution | |
| T80A4U0213 | In distribution | |
| T80A2U0452 | In distribution | |
| T80C3U0303 | In distribution | |
| T82C4U025U | In distribution | |
| T80C1U0232 | In distribution | |
| T80C3U0212 | In distribution | |
| T80B2U0413 | In distribution | |
| T80B3U0204 | In distribution | |
| T84A3L035L | In distribution | |
| T80A5U0413 | In distribution | |
| T82A2U022U | In distribution | |
| T80B4U0303 | In distribution | |
| T80A5L0083 | In distribution | |
| T80C3U0232 | In distribution | |
| T80D2U0334 | In distribution | |
| T80B3U0234 | In distribution | |
| T80D2U0201 | In distribution | |
| T82B1L026L | In distribution | |
| T80B3U0262 | In distribution | |
| T80C4U0204 | In distribution | |
| T80B1U0423 | In distribution | |
| T84A5U036U | In distribution | |
| T82C1L026L | In distribution | |
| T80C2U0232 | In distribution | |
| T80D2U0264 | In distribution | |
| T80C1U0333 | In distribution | |
| T80D3U0262 | In distribution | |
| T80A2U0264 | In distribution | |
| T80C2L0082 | In distribution | |
| T84B4U036U | In distribution | |
| T84C1U036U | In distribution | |
| T80C4U0233 | In distribution | |
| T80C2U0304 | In distribution | |
| T80D4U0233 | In distribution | |
| T80A1U0452 | In distribution | |
| T80C2L0053 | In distribution | |
| T82C2L026L | In distribution | |
| T80A1U0343 | In distribution | |
| T84A3U032U | In distribution | |
| T82A4L25SL | In distribution | |
| T80B4U0302 | In distribution | |
| T80B3L0052 | In distribution | |
| T82A2U25SU | In distribution | |
| T80C3U0343 | In distribution | |
| T80B4U0234 | In distribution | |
| T84D3U035U | In distribution | |
| T84A2L035L | In distribution | |
| T80A4U0234 | In distribution | |
| T80D4U0403 | In distribution | |
| T80B4U0412 | In distribution | |
| T80A3U0412 | In distribution | |
| T80B1U0452 | In distribution | |
| T80B4U0232 | In distribution | |
| T80C3U0233 | In distribution | |
| T82B4L25SL | In distribution | |
| T80A5L0082 | In distribution | |
| T84B2U036U | In distribution | |
| T80B3L0082 | In distribution | |
| T84D2L035L | In distribution | |
| T84B3U032U | In distribution | |
| T80D3U0353 | In distribution | |
| T80B2U0201 | In distribution | |
| T80B4L0081 | In distribution | |
| T80D2U0343 | In distribution | |
| T80C3U0302 | In distribution | |
| T84D4L035L | In distribution | |
| T84C1L032L | In distribution | |
| T80C4U0213 | In distribution | |
| T82D3U25SU | In distribution | |
| T80B1U0304 | In distribution | |
| T82B3U022U | In distribution | |
| T84D3L032L | In distribution | |
| T82A5L022L | In distribution | |
| T80D2U0352 | In distribution | |
| T80B1L0053 | In distribution | |
| T80D2U0303 | In distribution | |
| T80A3U0203 | In distribution | |
| T80B3U0425 | In distribution | |
| T84B3L032L | In distribution | |
| T80B3U0343 | In distribution | |
| T80C4U0264 | In distribution | |
| T84C1L038L | In distribution | |
| T80A5U0201 | In distribution | |
| T80A3U0452 | In distribution | |
| T84C4U032U | In distribution | |
| T80C3U0262 | In distribution | |
| T80A3U0453 | In distribution | |
| T84A2U032U | In distribution | |
| T80D2U0302 | In distribution | |
| T84C1U032U | In distribution | |
| T80B3U0413 | In distribution | |
| T80A2U0412 | In distribution | |
| T80A3L0083 | In distribution | |
| T82C2U022U | In distribution | |
| T80B1U0332 | In distribution | |
| T84A4L036L | In distribution | |
| T84D2U038U | In distribution | |
| T84C1L036L | In distribution | |
| T80C1U0262 | In distribution | |
| T82A5L025L | In distribution | |
| T80A3U0262 | In distribution | |
| T80C1U0334 | In distribution | |
| T80A1U0262 | In distribution | |
| T84C2L035L | In distribution | |
| T80D4U0302 | In distribution | |
| T82D3L25SL | In distribution | |
| T84A1L035L | In distribution | |
| T82B1L025L | In distribution | |
| T82D2U025U | In distribution | |
| T80B3U0303 | In distribution | |
| T80A2U0413 | In distribution | |
| T80B2L0080 | In distribution | |
| T80C4U0425 | In distribution | |
| T84A4L035L | In distribution | |
| T80C4U0403 | In distribution | |
| T82A2U025U | In distribution | |
| T80B2U0333 | In distribution | |
| T80C2L0083 | In distribution | |
| T80C1U0342 | In distribution | |
| T80D3U0212 | In distribution | |
| T80C1L0082 | In distribution | |
| T80D3U0425 | In distribution | |
| T84C2L032L | In distribution | |
| T80B1U0202 | In distribution | |
| T82C4U026U | In distribution | |
| T80A3U0352 | In distribution | |
| T80A1U0302 | In distribution | |
| T84A1L036L | In distribution | |
| T80A1U0202 | In distribution | |
| T80D3U0423 | In distribution | |
| T80C2U0353 | In distribution | |
| T80A2U0353 | In distribution | |
| T80D4L0081 | In distribution | |
| T80D3U0333 | In distribution | |
| T80C2U0413 | In distribution | |
| T80C4U0333 | In distribution | |
| T80D4U0213 | In distribution | |
| T80C4U0201 | In distribution | |
| T80B2U0233 | In distribution | |
| T80C3U0202 | In distribution | |
| T82A2L025L | In distribution | |
| T80D2U0204 | In distribution | |
| T80D4U0452 | In distribution | |
| T80C3U0342 | In distribution | |
| T80D2L0081 | In distribution | |
| T80A4U0263 | In distribution | |
| T80D2U0212 | In distribution | |
| T84A2L032L | In distribution | |
| T80D4U0412 | In distribution | |
| T82B4L022L | In distribution | |
| T82C2U026U | In distribution | |
| T80D4U0453 | In distribution | |
| T80C4U0334 | In distribution | |
| T80B4L0082 | In distribution | |
| T80A2U0334 | In distribution | |
| T80A5L0080 | In distribution | |
| T80B4U0423 | In distribution | |
| T80C2U0352 | In distribution | |
| T82A2L026L | In distribution | |
| T80C1U0224 | In distribution | |
| T80C4U0342 | In distribution | |
| T82B2U025U | In distribution | |
| T80B2U0212 | In distribution | |
| T80A2L0083 | 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.