Dentoluxx V
1,206 catalogue numbers from Anterior 1R Lower C2, listed by Wright Medical Technology, Inc., United States, under Denture, Plastic, Teeth. 26 manufacturers in China are registered for this product code.
26manufacturers in China registered for this device type
1,206catalogue numbers in this listing
1510(k) clearance
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 | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Anterior 1R Lower C2 | In distribution | |
| Posterior PD Upper C4 | In distribution | |
| Posterior 33L Lower A2 | In distribution | |
| Posterior PE Lower A4 | In distribution | |
| Posterior PBS Lower BL | In distribution | |
| Posterior PD Upper C2 | In distribution | |
| Anterior 266 Upper A1 | In distribution | |
| Posterior 29L Lower D4 | In distribution | |
| Anterior 35 Lower BL | In distribution | |
| Posterior 31L Upper BL | In distribution | |
| Posterior 31Z Upper D4 | In distribution | |
| Anterior 2N Lower A4 | In distribution | |
| Posterior 31L Upper B4 | In distribution | |
| Anterior 4H Upper B1 | In distribution | |
| Dentoluxx V Posterior 29Z Upper B2 | In distribution | |
| Anterior 1R Lower D3 | In distribution | |
| Anterior 1N Lower A3.5 | In distribution | |
| Dentoluxx V Posterior 29Z Upper B1 | In distribution | |
| Anterior 35 Lower A3.5 | In distribution | |
| Anterior 154 Upper D4 | In distribution | |
| Posterior PDS Upper B1 | In distribution | |
| Posterior PA Lower D3 | In distribution | |
| Posterior 31RF Lower C4 | In distribution | |
| Posterior PE Lower B1 | In distribution | |
| Anterior 3R Upper B4 | In distribution | |
| Anterior 24 Lower D2 | In distribution | |
| Posterior 31L Lower BL | In distribution | |
| Posterior 31RF Upper C4 | In distribution | |
| Anterior 3C Lower A3.5 | In distribution | |
| Anterior 3P Upper B3 | In distribution | |
| Posterior PF Upper D2 | In distribution | |
| Posterior 31M Upper A4 | In distribution | |
| Anterior 1R Lower A2 | In distribution | |
| Anterior 234 Upper B3 | In distribution | |
| Posterior PBS Lower B1 | In distribution | |
| Anterior 3R Upper D4 | In distribution | |
| Anterior 25 Upper C1 | In distribution | |
| Anterior 32 Lower C3 | In distribution | |
| Anterior 266 Upper B2 | In distribution | |
| Anterior 2P Lower D2 | In distribution | |
| Anterior 32 Lower B4 | In distribution | |
| Dentoluxx V Posterior 29Z Upper BL | In distribution | |
| Anterior 35 Lower C1 | In distribution | |
| Posterior PDS Lower D2 | In distribution | |
| Anterior PE Upper B1 | In distribution | |
| Posterior PA Upper C4 | In distribution | |
| Posterior PC Upper A1 | In distribution | |
| Anterior 3N Upper A3 | In distribution | |
| Posterior PA Upper B3 | In distribution | |
| Anterior 264 Upper C4 | In distribution | |
| Posterior PE Lower D2 | In distribution | |
| Posterior 29RF Upper BL | In distribution | |
| Anterior 2N Upper A2 | In distribution | |
| Posterior PBS Lower B3 | In distribution | |
| Posterior PDS Upper C2 | In distribution | |
| Dentoluxx V Posterior 29Z Lower D4 | In distribution | |
| Posterior 31M Lower D3 | In distribution | |
| Anterior 3R Upper A3.5 | In distribution | |
| Anterior 2D Upper C3 | In distribution | |
| Posterior 31Z Lower A3.5 | In distribution | |
| Posterior PE Upper A3.5 | In distribution | |
| Posterior 31RF Lower D2 | In distribution | |
| Anterior A26 Upper A3 | In distribution | |
| Anterior 2P Upper B3 | In distribution | |
| Anterior 3P Upper BL | In distribution | |
| Posterior PF Upper D4 | In distribution | |
| Anterior 3P Lower A4 | In distribution | |
| Posterior 31M Upper BL | In distribution | |
| Anterior 3C Upper D4 | In distribution | |
| Anterior 3C Lower B4 | In distribution | |
| Posterior 31RF Lower D4 | In distribution | |
| Anterior 32 Lower B3 | In distribution | |
| Anterior 24 Lower B4 | In distribution | |
| Posterior 29L Lower A3 | In distribution | |
| Anterior 2P Upper D3 | In distribution | |
| Posterior 31RF Upper A3 | In distribution | |
| Posterior PDS Lower A2 | In distribution | |
| Posterior PB Lower B3 | In distribution | |
| Dentoluxx V Posterior 29Z Upper C4 | In distribution | |
| Posterior 31L Upper B1 | In distribution | |
| Posterior 31Z Lower BL | In distribution | |
| Anterior 3C Upper A1 | In distribution | |
| Anterior 1H upper D2 | In distribution | |
| Anterior 234 Upper A3.5 | In distribution | |
| Posterior PA Lower C1 | In distribution | |
| Anterior 1H Lower B2 | In distribution | |
| Posterior PD Lower B3 | In distribution | |
| Anterior 35 Lower D3 | In distribution | |
| Posterior PA Lower BL | In distribution | |
| Posterior 29RF Upper C4 | In distribution | |
| Anterior 3C Lower B2 | In distribution | |
| Posterior PF Upper BL | In distribution | |
| Anterior 25 Lower D3 | In distribution | |
| Anterior 2N Lower B2 | In distribution | |
| Posterior 29L Lower D3 | In distribution | |
| Posterior 31L Lower B2 | In distribution | |
| Posterior 31RF Upper C1 | In distribution | |
| Dentoluxx V Posterior 33M Upper D2 | In distribution | |
| Anterior 3P Lower BL | In distribution | |
| Dentoluxx V Posterior 33M Upper C4 | In distribution | |
| Posterior PC Lower C1 | In distribution | |
| Anterior 4H Upper C2 | In distribution | |
| Anterior 324 Upper BL | In distribution | |
| Anterior 3C Upper C3 | In distribution | |
| Posterior 31M Upper C3 | In distribution | |
| Anterior 3D Upper A3 | In distribution | |
| Anterior 5P Upper B2 | In distribution | |
| Anterior 2P Upper A4 | In distribution | |
| Posterior PC Lower D3 | In distribution | |
| Anterior 135 Upper A3 | In distribution | |
| Anterior 2N Upper A4 | In distribution | |
| Anterior A26 Upper D3 | In distribution | |
| Posterior 29L Upper A4 | In distribution | |
| Posterior PB Lower D4 | In distribution | |
| Posterior PE Lower B3 | In distribution | |
| Posterior 31M Upper A2 | In distribution | |
| Anterior 3C Upper B4 | In distribution | |
| Anterior 1H Lower C1 | In distribution | |
| Anterior 2N Lower B4 | In distribution | |
| Posterior 31L Upper C3 | In distribution | |
| Posterior 29RF Lower C2 | In distribution | |
| Anterior 24 Lower D4 | In distribution | |
| Anterior 2P Lower B1 | In distribution | |
| Anterior 264 Upper A4 | In distribution | |
| Anterior 1H Upper A2 | In distribution | |
| Anterior 2N Lower BL | In distribution | |
| Dentoluxx V Posterior 29Z Lower B3 | In distribution | |
| Posterior 31L Upper C2 | In distribution | |
| Posterior 31Z Upper B2 | In distribution | |
| Posterior 31M Upper B2 | In distribution | |
| Anterior 1H Lower BL | In distribution | |
| Posterior 33M Upper A3.5 | In distribution | |
| Anterior 32 Lower A1 | In distribution | |
| Anterior 1R Lower A4 | In distribution | |
| Anterior 3D Upper A4 | In distribution | |
| Posterior 31M Lower D2 | In distribution | |
| Posterior PE Lower A3 | In distribution | |
| Anterior 324 Upper B4 | In distribution | |
| Anterior 135 Upper A1 | In distribution | |
| Anterior 266 Upper B4 | In distribution | |
| Anterior 234 Upper C1 | In distribution | |
| Anterior A25 Upper A3 | In distribution | |
| Anterior 2P Lower A3.5 | In distribution | |
| Posterior PDS Lower B2 | In distribution | |
| Dentoluxx V Posterior 29Z Upper A4 | In distribution | |
| Anterior 5P Lower D3 | In distribution | |
| Posterior PE Lower C1 | In distribution | |
| Anterior 3R Upper B2 | In distribution | |
| Posterior 29L Upper C4 | In distribution | |
| Anterior 2N Lower A1 | In distribution | |
| Posterior 31Z Lower B4 | In distribution | |
| Anterior 3P Lower D3 | In distribution | |
| Anterior 324 Upper A4 | In distribution | |
| Anterior 266 Upper C4 | In distribution | |
| Posterior PA Upper B4 | In distribution | |
| Anterior A25 Upper D2 | In distribution | |
| Dentoluxx V Posterior 33M Upper D4 | In distribution | |
| Anterior A26 Upper B2 | In distribution | |
| Posterior 29M Upper C1 | In distribution | |
| Anterior 3C Upper B2 | In distribution | |
| Posterior 33M Upper B1 | In distribution | |
| Anterior 324 Upper B3 | In distribution | |
| Posterior 31Z Lower A3 | In distribution | |
| Posterior 29M Upper D3 | In distribution | |
| Anterior 25 Upper B2 | In distribution | |
| Anterior 25 Lower C3 | In distribution | |
| Posterior 29L Upper D4 | In distribution | |
| Posterior 31M Upper D2 | In distribution | |
| Posterior PB Lower C4 | In distribution | |
| Posterior 33L Upper C4 | In distribution | |
| Anterior 25 Upper C2 | In distribution | |
| Anterior 3C Upper A3 | In distribution | |
| Anterior 266 Upper D4 | In distribution | |
| Anterior 135 Upper C3 | In distribution | |
| Posterior 33L Lower A3 | In distribution | |
| Posterior PE Upper A4 | In distribution | |
| Posterior 29M Lower D3 | In distribution | |
| Anterior 2N Upper A3 | In distribution | |
| Anterior 3C Lower C4 | In distribution | |
| Anterior 3N Upper A1 | In distribution | |
| Anterior 4H Upper A3 | In distribution | |
| Anterior 2D Upper A1 | In distribution | |
| Anterior 274 Upper A2 | In distribution | |
| Posterior PC Lower B1 | In distribution | |
| Anterior 1R Lower A1 | In distribution | |
| Anterior 3C Lower C3 | In distribution | |
| Posterior PA Upper D2 | In distribution | |
| Posterior 33L Lower C4 | In distribution | |
| Anterior 2D Upper B1 | In distribution | |
| Anterior 135 Upper B4 | In distribution | |
| Posterior 29M Upper A2 | In distribution | |
| Anterior 25 Lower A4 | In distribution | |
| Anterior A25 Upper BL | In distribution | |
| Anterior 1H upper D4 | In distribution | |
| Posterior 31M Lower A4 | In distribution | |
| Posterior PA Upper A4 | In distribution | |
| Posterior PE Lower C4 | In distribution | |
| Posterior 31RF Upper D4 | In distribution | |
| Anterior 234 Upper A1 | In distribution | |
| Posterior 29L Upper B3 | In distribution | |
| Anterior 1H upper A3.5 | In distribution | |
| Anterior 5P Upper D3 | In distribution | |
| Posterior 29L Lower B4 | In distribution | |
| Posterior PD Lower A4 | In distribution | |
| Posterior 33L Lower A4 | In distribution | |
| Anterior 24 Lower B2 | In distribution | |
| Posterior 31L Upper C4 | In distribution | |
| Posterior PD Lower A3.5 | In distribution | |
| Posterior 29RF Upper D2 | In distribution | |
| Anterior A25 Upper D3 | In distribution | |
| Posterior PB Upper D3 | In distribution | |
| Posterior 31L Lower A3.5 | In distribution | |
| Posterior PA Lower A4 | In distribution | |
| Posterior PBS Upper C4 | In distribution | |
| Anterior 3R Upper A2 | In distribution | |
| Dentoluxx V Posterior 33M Lower D2 | In distribution | |
| Anterior 264 Upper A2 | In distribution | |
| Anterior 1N Lower C1 | In distribution | |
| Posterior 29M Lower A3.5 | In distribution | |
| Anterior 3C Lower D3 | In distribution | |
| Posterior PBS Lower D4 | In distribution | |
| Anterior 1N Lower D3 | In distribution | |
| Posterior PD Upper A4 | In distribution | |
| Anterior 2N Upper A3.5 | In distribution | |
| Posterior 29M Lower BL | In distribution | |
| Anterior 1H Lower B3 | In distribution | |
| Anterior 154 Upper D3 | In distribution | |
| Posterior 31L Lower D2 | In distribution | |
| Anterior 5P Upper BL | In distribution | |
| Anterior 324 Upper A2 | In distribution | |
| Anterior 5P Lower B4 | In distribution | |
| Anterior 135 Upper A4 | In distribution | |
| Anterior 2N Lower C3 | In distribution | |
| Anterior 324 Upper A3 | In distribution | |
| Posterior 29M Upper D2 | In distribution | |
| Anterior 1N Upper A1 | In distribution | |
| Posterior PC Lower A3 | In distribution | |
| Posterior PD Upper B2 | In distribution | |
| Anterior 5P Upper B4 | In distribution | |
| Anterior UY Upper C1 | In distribution | |
| Anterior 1N Lower D4 | In distribution | |
| Posterior PC Lower A2 | In distribution | |
| Posterior 33L Lower A1 | In distribution | |
| Anterior 1R Lower A3.5 | In distribution | |
| Posterior PC Upper B1 | In distribution | |
| Posterior PE Lower C3 | In distribution | |
| Posterior 33L Upper D3 | In distribution | |
| Posterior 29M Lower A3 | In distribution | |
| Anterior 4H Lower C1 | In distribution | |
| Posterior 29RF Upper D4 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122955 | 2013-03-01 |
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.