Ortolux TOP
ORTOLUX TOP posterior Teeth Shade A3,5, Mould 29MZ low.
26manufacturers in China registered for this device type
1,370catalogue 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 | Union Dental SA |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| 510(k) | K070591 |
| Record published | 2024-09-17 |
| Record revised | 2021-12-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| POSTERIOR TEETH 77/33MS | In distribution | |
| POSTERIOR TEETH A3,5/50S | In distribution | |
| ANTERIOR TEETH 66/4H | In distribution | |
| POSTERIOR TEETH B4/29S | In distribution | |
| POSTERIOR TEETH 59/29LLI | In distribution | |
| POSTERIOR TEETH B4/F32I | In distribution | |
| POSTERIOR TEETH 81/29MZI | In distribution | |
| ANTERIOR TEETH B1/4H | In distribution | |
| POSTERIOR TEETH B1/33MS | In distribution | |
| ANTERIOR TEETH 81/2N | In distribution | |
| POSTERIOR TEETH 62/29MZI | In distribution | |
| ANTERIOR TEETH A0/90 | In distribution | |
| POSTERIOR TEETH A2/32I | In distribution | |
| POSTERIOR TEETH A4/29LLS | In distribution | |
| POSTERIOR TEETH C2/F34S | In distribution | |
| POSTERIOR TEETH A2/33MS | In distribution | |
| POSTERIOR TEETH A2/32S | In distribution | |
| POSTERIOR TEETH A4/F34S | In distribution | |
| ANTERIOR TEETH 81/1H | In distribution | |
| ANTERIOR TEETH D4/1N | In distribution | |
| POSTERIOR TEETH B2/33S | In distribution | |
| POSTERIOR TEETH A3,5/33I | In distribution | |
| ANTERIOR TEETH 68/23 | In distribution | |
| POSTERIOR TEETH A3/33MS | In distribution | |
| POSTERIOR TEETH B1/29I | In distribution | |
| ANTERIOR TEETH D4/21 | In distribution | |
| POSTERIOR TEETH 59/29MZI | In distribution | |
| POSTERIOR TEETH 59/F32S | In distribution | |
| POSTERIOR TEETH 81/33MS | In distribution | |
| ANTERIOR TEETH B1/13 | In distribution | |
| POSTERIOR TEETH 60/31S | In distribution | |
| POSTERIOR TEETH D4/34I | In distribution | |
| POSTERIOR TEETH 67/F32S | In distribution | |
| ANTERIOR TEETH 67/4 | In distribution | |
| POSTERIOR TEETH 65/29MZS | In distribution | |
| ANTERIOR TEETH A0/3D | In distribution | |
| ANTERIOR TEETH A1/3R | In distribution | |
| ANTERIOR TEETH C2/20 | In distribution | |
| POSTERIOR TEETH C1/31I | In distribution | |
| POSTERIOR TEETH D4/34S | In distribution | |
| POSTERIOR TEETH A2/29LLI | In distribution | |
| POSTERIOR TEETH 60/F34S | In distribution | |
| ANTERIOR TEETH C2/1N | In distribution | |
| POSTERIOR TEETH C1/29S | In distribution | |
| POSTERIOR TEETH 66/29MZI | In distribution | |
| ANTERIOR TEETH A3/2D | In distribution | |
| POSTERIOR TEETH A0/29I | In distribution | |
| ANTERIOR TEETH 62/1NN | In distribution | |
| ANTERIOR TEETH 77/A25 | In distribution | |
| POSTERIOR TEETH A0/31I | In distribution | |
| POSTERIOR TEETH 59/29MZS | In distribution | |
| ANTERIOR TEETH 65/1N | In distribution | |
| ANTERIOR TEETH 60/A25 | In distribution | |
| POSTERIOR TEETH 59/34I | In distribution | |
| POSTERIOR TEETH 62/54I | In distribution | |
| POSTERIOR TEETH 67/50I | In distribution | |
| ANTERIOR TEETH 66/3D | In distribution | |
| POSTERIOR TEETH 77/50S | In distribution | |
| POSTERIOR TEETH 60/33MI | In distribution | |
| POSTERIOR TEETH 67/33LS | In distribution | |
| POSTERIOR TEETH B4/29I | In distribution | |
| POSTERIOR TEETH C1/50S | In distribution | |
| POSTERIOR TEETH D4/F32S | In distribution | |
| POSTERIOR TEETH 67/52S | In distribution | |
| POSTERIOR TEETH B4/34I | In distribution | |
| ANTERIOR TEETH B4/4H | In distribution | |
| POSTERIOR TEETH C2/F32I | In distribution | |
| ANTERIOR TEETH B1/3P | In distribution | |
| ANTERIOR TEETH 65/1NN | In distribution | |
| POSTERIOR TEETH 60/50S | In distribution | |
| POSTERIOR TEETH 59/54I | In distribution | |
| POSTERIOR TEETH 65/33S | In distribution | |
| POSTERIOR TEETH 68/31S | In distribution | |
| POSTERIOR TEETH A1/34I | In distribution | |
| ANTERIOR TEETH 66/90 | In distribution | |
| POSTERIOR TEETH D4/54I | In distribution | |
| POSTERIOR TEETH B1/33LS | In distribution | |
| POSTERIOR TEETH D4/54S | In distribution | |
| POSTERIOR TEETH A2/33MI | In distribution | |
| ANTERIOR TEETH A3,5/9 | In distribution | |
| ANTERIOR TEETH A3,5/5 | In distribution | |
| ANTERIOR TEETH D4/15 | In distribution | |
| ANTERIOR TEETH B4/136 | In distribution | |
| ANTERIOR TEETH 65/3M | In distribution | |
| POSTERIOR TEETH C1/50I | In distribution | |
| ANTERIOR TEETH 67/1N | In distribution | |
| ANTERIOR TEETH A3,5/3NN | In distribution | |
| POSTERIOR TEETH 60/52I | In distribution | |
| POSTERIOR TEETH A4/33LI | In distribution | |
| POSTERIOR TEETH A0/52S | In distribution | |
| POSTERIOR TEETH 77/54I | In distribution | |
| ANTERIOR TEETH A3,5/4H | In distribution | |
| ANTERIOR TEETH C1/3N | In distribution | |
| ANTERIOR TEETH A4/15 | In distribution | |
| POSTERIOR TEETH D3/29MZS | In distribution | |
| ANTERIOR TEETH B2/3P | In distribution | |
| ANTERIOR TEETH 66/1NN | In distribution | |
| ANTERIOR TEETH A1/9 | In distribution | |
| POSTERIOR TEETH B2/29S | In distribution | |
| POSTERIOR TEETH 60/54I | In distribution | |
| POSTERIOR TEETH A1/50I | In distribution | |
| POSTERIOR TEETH 66/33S | In distribution | |
| ANTERIOR TEETH C2/9 | In distribution | |
| POSTERIOR TEETH A1/33MI | In distribution | |
| ANTERIOR TEETH 65/1H | In distribution | |
| POSTERIOR TEETH 59/33S | In distribution | |
| ANTERIOR TEETH A1/3P | In distribution | |
| POSTERIOR TEETH A1/54S | In distribution | |
| POSTERIOR TEETH C1/F32I | In distribution | |
| ANTERIOR TEETH 60/136 | In distribution | |
| POSTERIOR TEETH A3,5/29S | In distribution | |
| POSTERIOR TEETH 66/33MI | In distribution | |
| POSTERIOR TEETH B0/F32I | In distribution | |
| POSTERIOR TEETH A3,5/32I | In distribution | |
| ANTERIOR TEETH A0/4H | In distribution | |
| ANTERIOR TEETH A4/226 | In distribution | |
| ANTERIOR TEETH B0/2DD | In distribution | |
| ANTERIOR TEETH D3/13 | In distribution | |
| ANTERIOR TEETH 66/62 | In distribution | |
| ANTERIOR TEETH B0/62 | In distribution | |
| POSTERIOR TEETH 69/32I | In distribution | |
| POSTERIOR TEETH A2/29I | In distribution | |
| ANTERIOR TEETH A2/13 | In distribution | |
| ANTERIOR TEETH 62/2P | In distribution | |
| ANTERIOR TEETH B1/3N | In distribution | |
| ANTERIOR TEETH A3/1N | In distribution | |
| POSTERIOR TEETH C2/33I | In distribution | |
| ANTERIOR TEETH 77/A26 | In distribution | |
| POSTERIOR TEETH 59/32S | In distribution | |
| POSTERIOR TEETH C1/33MS | In distribution | |
| ANTERIOR TEETH C1/3R | In distribution | |
| POSTERIOR TEETH 66/31I | In distribution | |
| ANTERIOR TEETH B1/9 | In distribution | |
| ANTERIOR TEETH D4/3NN | In distribution | |
| POSTERIOR TEETH A2/29LLS | In distribution | |
| POSTERIOR TEETH 67/29LLS | In distribution | |
| ANTERIOR TEETH A2/5 | In distribution | |
| ANTERIOR TEETH A4/2DD | In distribution | |
| POSTERIOR TEETH C1/34I | In distribution | |
| POSTERIOR TEETH 66/29LLI | In distribution | |
| POSTERIOR TEETH A2/34I | In distribution | |
| POSTERIOR TEETH 66/F32I | In distribution | |
| POSTERIOR TEETH B2/50S | In distribution | |
| ANTERIOR TEETH 59/15 | In distribution | |
| ANTERIOR TEETH 59/1NN | In distribution | |
| POSTERIOR TEETH A3,5/29LLS | In distribution | |
| POSTERIOR TEETH A0/29LLI | In distribution | |
| ANTERIOR TEETH 69/3R | In distribution | |
| ANTERIOR TEETH 81/4 | In distribution | |
| ANTERIOR TEETH 81/1NN | In distribution | |
| ANTERIOR TEETH 68/3P | In distribution | |
| ANTERIOR TEETH C2/136 | In distribution | |
| ANTERIOR TEETH 62/21 | In distribution | |
| ANTERIOR TEETH 69/90 | In distribution | |
| ANTERIOR TEETH B4/3NN | In distribution | |
| ANTERIOR TEETH 77/9 | In distribution | |
| POSTERIOR TEETH 59/33LS | In distribution | |
| POSTERIOR TEETH 62/50I | In distribution | |
| POSTERIOR TEETH 66/33LI | In distribution | |
| ANTERIOR TEETH 66/1N | In distribution | |
| ANTERIOR TEETH 65/2N | In distribution | |
| POSTERIOR TEETH B2/54S | In distribution | |
| POSTERIOR TEETH C2/31I | In distribution | |
| ANTERIOR TEETH 68/20 | In distribution | |
| POSTERIOR TEETH 62/31S | In distribution | |
| POSTERIOR TEETH D3/31I | In distribution | |
| ANTERIOR TEETH D4/A25 | In distribution | |
| POSTERIOR TEETH A0/33MS | In distribution | |
| POSTERIOR TEETH A3/F34I | In distribution | |
| POSTERIOR TEETH 67/52I | In distribution | |
| POSTERIOR TEETH 59/52I | In distribution | |
| POSTERIOR TEETH B0/29S | In distribution | |
| ANTERIOR TEETH 81/4H | In distribution | |
| POSTERIOR TEETH 68/32I | In distribution | |
| POSTERIOR TEETH 59/32I | In distribution | |
| POSTERIOR TEETH D4/F32I | In distribution | |
| ANTERIOR TEETH D4/3N | In distribution | |
| ANTERIOR TEETH B0/4H | In distribution | |
| POSTERIOR TEETH B4/33I | In distribution | |
| ANTERIOR TEETH D4/3PP | In distribution | |
| ANTERIOR TEETH 77/1NN | In distribution | |
| POSTERIOR TEETH A3/F34S | In distribution | |
| ANTERIOR TEETH A4/3P | In distribution | |
| ANTERIOR TEETH C1/15 | In distribution | |
| POSTERIOR TEETH B2/29MZI | In distribution | |
| POSTERIOR TEETH 66/33MS | In distribution | |
| POSTERIOR TEETH A4/29MZS | In distribution | |
| ANTERIOR TEETH A4/136 | In distribution | |
| POSTERIOR TEETH 81/29S | In distribution | |
| ANTERIOR TEETH 66/20 | In distribution | |
| POSTERIOR TEETH C2/33LI | In distribution | |
| ANTERIOR TEETH C1/226 | In distribution | |
| ANTERIOR TEETH 81/3NN | In distribution | |
| ANTERIOR TEETH 68/62 | In distribution | |
| POSTERIOR TEETH B2/29I | In distribution | |
| ANTERIOR TEETH 59/21 | In distribution | |
| ANTERIOR TEETH B2/4H | In distribution | |
| POSTERIOR TEETH 59/52S | In distribution | |
| ANTERIOR TEETH D3/9 | In distribution | |
| POSTERIOR TEETH C2/32I | In distribution | |
| POSTERIOR TEETH 68/F34I | In distribution | |
| ANTERIOR TEETH 66/3NN | In distribution | |
| POSTERIOR TEETH D3/33LS | In distribution | |
| POSTERIOR TEETH 59/34S | In distribution | |
| ANTERIOR TEETH A1/3PP | In distribution | |
| POSTERIOR TEETH A1/52I | In distribution | |
| ANTERIOR TEETH 81/3D | In distribution | |
| ANTERIOR TEETH 68/4H | In distribution | |
| ANTERIOR TEETH 81/62 | In distribution | |
| POSTERIOR TEETH 66/50S | In distribution | |
| ANTERIOR TEETH D3/2N | In distribution | |
| ANTERIOR TEETH 65/A26 | In distribution | |
| POSTERIOR TEETH B0/32S | In distribution | |
| ANTERIOR TEETH B2/2D | In distribution | |
| POSTERIOR TEETH A0/29S | In distribution | |
| ANTERIOR TEETH 77/3R | In distribution | |
| ANTERIOR TEETH 81/A26 | In distribution | |
| POSTERIOR TEETH 68/34I | In distribution | |
| ANTERIOR TEETH 60/4 | In distribution | |
| ANTERIOR TEETH B1/2N | In distribution | |
| ANTERIOR TEETH A3/1H | In distribution | |
| ANTERIOR TEETH A2/20 | In distribution | |
| ANTERIOR TEETH B2/9 | In distribution | |
| POSTERIOR TEETH 66/34I | In distribution | |
| POSTERIOR TEETH A4/33I | In distribution | |
| ANTERIOR TEETH 59/3M | In distribution | |
| POSTERIOR TEETH 66/29S | In distribution | |
| POSTERIOR TEETH B2/31I | In distribution | |
| POSTERIOR TEETH 62/52I | In distribution | |
| ANTERIOR TEETH B4/9 | In distribution | |
| POSTERIOR TEETH C1/34S | In distribution | |
| ANTERIOR TEETH B0/2N | In distribution | |
| POSTERIOR TEETH A0/F34S | In distribution | |
| ANTERIOR TEETH A4/3R | In distribution | |
| ANTERIOR TEETH 77/1H | In distribution | |
| ANTERIOR TEETH 66/9 | In distribution | |
| ANTERIOR TEETH 69/3PP | In distribution | |
| ANTERIOR TEETH B1/1N | In distribution | |
| ANTERIOR TEETH D3/1NN | In distribution | |
| POSTERIOR TEETH D3/34I | In distribution | |
| POSTERIOR TEETH 65/54S | In distribution | |
| POSTERIOR TEETH 68/50S | In distribution | |
| ANTERIOR TEETH 60/23 | In distribution | |
| POSTERIOR TEETH C2/29MZS | In distribution | |
| ANTERIOR TEETH A0/A25 | In distribution | |
| POSTERIOR TEETH B4/33MI | In distribution | |
| POSTERIOR TEETH D4/50S | In distribution | |
| ANTERIOR TEETH 68/1NN | In distribution | |
| ANTERIOR TEETH B4/21 | In distribution | |
| ANTERIOR TEETH A1/2DD | 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.