Dentavit
1,378 catalogue numbers from Posterior PBS lower BL, 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
1,378catalogue 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 |
|---|---|---|
| Posterior PBS lower BL | In distribution | |
| Posterior 31S upper C2 | In distribution | |
| Anterior A26 upper B1 | In distribution | |
| Posterior 29L lower C3 | In distribution | |
| Anterior 2C upper D2 | In distribution | |
| Anterior 274 upper C2 | In distribution | |
| Posterior PDS lower D2 | In distribution | |
| Posterior 33M lower A2 | In distribution | |
| Posterior 29RF Upper D4 | In distribution | |
| Anterior 324 Upper BL | In distribution | |
| Anterior 154 upper A4 | In distribution | |
| Posterior 29M lower A3 | In distribution | |
| Anterior 274 upper C3 | In distribution | |
| Posterior 33M lower BL | In distribution | |
| Posterior 29M lower C1 | In distribution | |
| Anterior 2P upper A2 | In distribution | |
| Posterior 31M lower A4 | In distribution | |
| Posterior 31S upper B4 | In distribution | |
| Anterior 4H upper B1 | In distribution | |
| Posterior PA lower A2 | In distribution | |
| Posterior 31L lower B1 | In distribution | |
| Anterior 324 upper C4 | In distribution | |
| Anterior 5P lower B3 | In distribution | |
| Anterior 223 upper A3 | In distribution | |
| Posterior 31RF lower A2 | In distribution | |
| Posterior 29Z lower C4 | In distribution | |
| Anterior 274 upper B1 | In distribution | |
| Anterior 2P upper C3 | In distribution | |
| Posterior PA upper B2 | In distribution | |
| Anterior 156 upper A1 | In distribution | |
| Anterior 3C lower B2 | In distribution | |
| Anterior 5P lower D2 | In distribution | |
| Anterior 2N Lower BL | In distribution | |
| Posterior 31RF upper B4 | In distribution | |
| Anterior 4H lower B3 | In distribution | |
| Anterior A26 upper A2 | In distribution | |
| Anterior 234 upper D3 | In distribution | |
| Posterior 31L lower C3 | In distribution | |
| Anterior 32 upper C3 | In distribution | |
| Anterior 35 lower A1 | In distribution | |
| Anterior 3D upper A3.5 | In distribution | |
| Anterior 3R upper B3 | In distribution | |
| Posterior PE lower A4 | In distribution | |
| Anterior 154 upper B4 | In distribution | |
| Anterior 3P lower A2 | In distribution | |
| Posterior PA upper A3.5 | In distribution | |
| Posterior PDS upper B3 | In distribution | |
| Anterior 3D upper A2 | In distribution | |
| Anterior 1N lower C2 | In distribution | |
| Anterior 4H lower C4 | In distribution | |
| Anterior 266 upper B4 | In distribution | |
| Anterior 3M upper B4 | In distribution | |
| Posterior 33M lower B4 | In distribution | |
| Anterior 3R upper A3 | In distribution | |
| Posterior 31M lower C3 | In distribution | |
| Posterior 31S upper D4 | In distribution | |
| Posterior 29M lower B2 | In distribution | |
| Posterior 33M upper C3 | In distribution | |
| Posterior 31M upper D4 | In distribution | |
| Anterior 223 upper D2 | In distribution | |
| Posterior 31RF upper A3 | In distribution | |
| Anterior 3M upper C1 | In distribution | |
| Posterior PC lower B1 | In distribution | |
| Posterior 29L lower B4 | In distribution | |
| Posterior 33M upper C1 | In distribution | |
| Posterior 33M lower B2 | In distribution | |
| Anterior A26 Upper BL | In distribution | |
| Posterior 31S lower D3 | In distribution | |
| Anterior UY upper C4 | In distribution | |
| Anterior 4H lower A4 | In distribution | |
| Posterior 31L upper D4 | In distribution | |
| Anterior 133 upper A3.5 | In distribution | |
| Anterior 154 upper D2 | In distribution | |
| Posterior PC lower B4 | In distribution | |
| Posterior PA lower D2 | In distribution | |
| Posterior 31L Upper B2 | In distribution | |
| Anterior 3P Lower BL | In distribution | |
| Posterior 31M lower C2 | In distribution | |
| Anterior 135 upper B1 | In distribution | |
| Anterior 25 lower D2 | In distribution | |
| Posterior 29L upper A1 | In distribution | |
| Posterior 29RF Upper B2 | In distribution | |
| Anterior 2P upper B4 | In distribution | |
| Posterior PBS lower C4 | In distribution | |
| Anterior 2P upper B3 | In distribution | |
| Posterior PD upper C2 | In distribution | |
| Posterior PC upper B1 | In distribution | |
| Anterior 24 lower A4 | In distribution | |
| Anterior 274 upper B4 | In distribution | |
| Posterior PD upper A2 | In distribution | |
| Posterior PC upper A3.5 | In distribution | |
| Anterior 25 upper C2 | In distribution | |
| Anterior 32 lower D3 | In distribution | |
| Posterior 31M upper A1 | In distribution | |
| Anterior 3D upper B3 | In distribution | |
| Anterior 3R upper C2 | In distribution | |
| Anterior 264 upper B4 | In distribution | |
| Posterior PB upper BL | In distribution | |
| Posterior 29L upper B4 | In distribution | |
| Anterior 2N lower C4 | In distribution | |
| Anterior 1H upper B1 | In distribution | |
| Posterior 31RF upper D2 | In distribution | |
| Anterior 3D Upper BL | In distribution | |
| Posterior PE upper A3.5 | In distribution | |
| Anterior 2P upper A4 | In distribution | |
| Posterior 31L upper A4 | In distribution | |
| Posterior 29L upper A3.5 | In distribution | |
| Anterior 23 lower B4 | In distribution | |
| Anterior 266 upper C3 | In distribution | |
| Posterior 29M upper D4 | In distribution | |
| Posterior 31S upper A3 | In distribution | |
| Posterior PBS lower D3 | In distribution | |
| Posterior PF lower A4 | In distribution | |
| Anterior 4H lower A3.5 | In distribution | |
| Anterior 2C upper B2 | In distribution | |
| Posterior 33L lower B1 | In distribution | |
| Anterior 274 upper D3 | In distribution | |
| Posterior PD upper B4 | In distribution | |
| Posterior PDS upper D2 | In distribution | |
| Anterior 1N upper D2 | In distribution | |
| Anterior 2C upper B3 | In distribution | |
| Posterior 33 upper C4 | In distribution | |
| Posterior PBS lower D2 | In distribution | |
| Anterior 2D upper A3 | In distribution | |
| Anterior 5P upper A2 | In distribution | |
| Posterior 31Z upper A4 | In distribution | |
| Anterior 324 upper B2 | In distribution | |
| Anterior 23 lower C4 | In distribution | |
| Anterior 274 upper A1 | In distribution | |
| Posterior PF upper D2 | In distribution | |
| Posterior PD upper C4 | In distribution | |
| Anterior 4H lower D2 | In distribution | |
| Anterior 5P upper D4 | In distribution | |
| Posterior PA upper C3 | In distribution | |
| Anterior 266 upper B2 | In distribution | |
| Anterior 4H upper C3 | In distribution | |
| Posterior 29L lower B1 | In distribution | |
| Anterior 24 lower C1 | In distribution | |
| Anterior 3N upper C4 | In distribution | |
| Posterior PD lower C4 | In distribution | |
| Posterior PDS upper A3.5 | In distribution | |
| Anterior 23 Lower BL | In distribution | |
| Posterior 29L upper C2 | In distribution | |
| Anterior 3D upper B1 | In distribution | |
| Anterior 3P lower D2 | In distribution | |
| Posterior PB lower D4 | In distribution | |
| Anterior 2D Upper BL | In distribution | |
| Posterior 31M upper D2 | In distribution | |
| Posterior 31Z upper A2 | In distribution | |
| Anterior 24 lower A1 | In distribution | |
| Posterior PBS upper C3 | In distribution | |
| Posterior 31L upper A2 | In distribution | |
| Anterior 32 Lower BL | In distribution | |
| Anterior 32 upper A4 | In distribution | |
| Anterior UY upper A3 | In distribution | |
| Anterior 1N upper C1 | In distribution | |
| Posterior PB lower D3 | In distribution | |
| Anterior 3N upper C2 | In distribution | |
| Anterior 24 Lower BL | In distribution | |
| Posterior PC lower A4 | In distribution | |
| Posterior PD upper B2 | In distribution | |
| Anterior 3R upper A2 | In distribution | |
| Anterior 24 lower D3 | In distribution | |
| Posterior 29Z lower A3 | In distribution | |
| Posterior 31Z lower C2 | In distribution | |
| Posterior PE upper B1 | In distribution | |
| Anterior 2C upper C3 | In distribution | |
| Posterior 29M upper C3 | In distribution | |
| Posterior PF upper B1 | In distribution | |
| Anterior A25 upper B3 | In distribution | |
| Anterior 2P upper B1 | In distribution | |
| Anterior 3C upper A4 | In distribution | |
| Posterior PC lower B3 | In distribution | |
| Anterior 156 upper B1 | In distribution | |
| Anterior 1H lower B1 | In distribution | |
| Posterior PB upper C1 | In distribution | |
| Posterior PBS lower B2 | In distribution | |
| Anterior 3C lower A4 | In distribution | |
| Anterior 3P lower B4 | In distribution | |
| Anterior UY upper B2 | In distribution | |
| Anterior 2N upper A2 | In distribution | |
| Posterior 31M upper A3.5 | In distribution | |
| Posterior 33 upper C3 | In distribution | |
| Posterior PDS upper BL | In distribution | |
| Posterior 29Z upper A1 | In distribution | |
| Posterior PB upper B2 | In distribution | |
| Anterior 5P lower C1 | In distribution | |
| Anterior 1N upper A3.5 | In distribution | |
| Posterior 29RF Upper D3 | In distribution | |
| Anterior 2N lower A4 | In distribution | |
| Posterior 31L lower A4 | In distribution | |
| Anterior 3M upper A2 | In distribution | |
| Anterior 3C Upper BL | In distribution | |
| Anterior 3P upper C4 | In distribution | |
| Anterior A25 upper A1 | In distribution | |
| Anterior 35 Lower BL | In distribution | |
| Anterior 1H Upper BL | In distribution | |
| Anterior 2N lower A3 | In distribution | |
| Posterior 31RF lower C4 | In distribution | |
| Anterior 154 upper D4 | In distribution | |
| Posterior 31Z lower A4 | In distribution | |
| Posterior 31RF lower C2 | In distribution | |
| Anterior 156 upper B2 | In distribution | |
| Posterior 29Z lower B2 | In distribution | |
| Anterior 135 upper A3.5 | In distribution | |
| Anterior 324 upper A2 | In distribution | |
| Anterior 4H upper A3.5 | In distribution | |
| Anterior 3P upper A3 | In distribution | |
| Anterior 3D upper D2 | In distribution | |
| Posterior 33M upper A4 | In distribution | |
| Posterior 33M upper D4 | In distribution | |
| Posterior PC lower C4 | In distribution | |
| Posterior 29RF Lower D3 | In distribution | |
| Anterior 264 upper B1 | In distribution | |
| Posterior 29Z upper C4 | In distribution | |
| Anterior 2D upper D4 | In distribution | |
| Anterior 3N upper B1 | In distribution | |
| Anterior 32 lower C3 | In distribution | |
| Anterior 3N upper B2 | In distribution | |
| Posterior 33M upper D3 | In distribution | |
| Anterior A26 upper C4 | In distribution | |
| Posterior PA upper C1 | In distribution | |
| Anterior 135 upper D4 | In distribution | |
| Posterior 33M lower A4 | In distribution | |
| Anterior 3N Upper BL | In distribution | |
| Anterior 3P lower C4 | In distribution | |
| Anterior 234 upper A3 | In distribution | |
| Posterior 33 upper A2 | In distribution | |
| Posterior PB upper A3 | In distribution | |
| Posterior PDS upper A4 | In distribution | |
| Anterior 154 upper C2 | In distribution | |
| Posterior 31L upper C1 | In distribution | |
| Posterior PC lower B2 | In distribution | |
| Anterior 2N lower D3 | In distribution | |
| Posterior 31S lower A2 | In distribution | |
| Anterior 133 upper B2 | In distribution | |
| Posterior 31S lower A4 | In distribution | |
| Anterior 32 lower B4 | In distribution | |
| Posterior 33 upper D3 | In distribution | |
| Anterior 23 lower D4 | In distribution | |
| Anterior 274 upper A3.5 | In distribution | |
| Anterior 3C upper A3.5 | In distribution | |
| Anterior 3P upper B3 | In distribution | |
| Anterior 2P upper A3 | In distribution | |
| Posterior PF upper BL | In distribution | |
| Anterior 1H upper A2 | In distribution | |
| Posterior 33M upper A1 | In distribution | |
| Anterior 1N upper B2 | In distribution | |
| Posterior 31Z lower D4 | In distribution | |
| Posterior 31L lower C2 | 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.