REF-Line
1,458 catalogue numbers from REF.Q5ZB3, listed by Polident d.o.o., under Denture, Plastic, Teeth. 26 manufacturers in China are registered for this product code.
26manufacturers in China registered for this device type
1,458catalogue 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 | Polident d.o.o. |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Premarket notification | Exempt |
| Record published | 2021-06-15 |
| Record revised | 2024-12-20 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: keep out of sunlight; Storage environment temperature -30 to 40 °C |
| Packaging | Plastic card, card |
| Sizes | Outer diameter 3 m |
| Distribution end date | 2024-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF.Q5ZB3 | In distribution | |
| REF.N3B1 | In distribution | |
| REF.V8C3 | In distribution | |
| REF.K4B2 | In distribution | |
| REF.U4B2 | In distribution | |
| REF.H4D3 | In distribution | |
| REF.R4SC3 | In distribution | |
| REF.N4B4 | In distribution | |
| REF.K3B3 | In distribution | |
| REF.R2SC4 | In distribution | |
| REF.V8C4 | In distribution | |
| REF.W6D4 | In distribution | |
| REF.Q3ZB2 | In distribution | |
| REF.V3A2 | In distribution | |
| REF.R6SA3 | In distribution | |
| REF.W6D2 | In distribution | |
| REF.K4B1 | In distribution | |
| REF.F4ZA9 | In distribution | |
| REF.F2SD3 | In distribution | |
| REF.N6L3 | In distribution | |
| REF.R6ZA2 | In distribution | |
| REF.K6C2 | In distribution | |
| REF.M3C3 | In distribution | |
| REF.U6B2 | In distribution | |
| REF.R2ZB3 | In distribution | |
| REF.R2SB2 | In distribution | |
| REF.R4ZA2 | In distribution | |
| REF.Q3SB2 | In distribution | |
| REF.F2SC3 | In distribution | |
| REF.R2SB1 | In distribution | |
| REF.M1B4 | In distribution | |
| REF.F4ZB4 | In distribution | |
| REF.W4C3 | In distribution | |
| REF.V8B1 | In distribution | |
| REF.F6SB3 | In distribution | |
| REF.V4B3 | In distribution | |
| REF.F6SA3 | In distribution | |
| REF.N3C3 | In distribution | |
| REF.R4SB3 | In distribution | |
| REF.U6D4 | In distribution | |
| REF.Q1ZC1 | In distribution | |
| REF.N3C4 | In distribution | |
| REF.N3B3 | In distribution | |
| REF.V8D3 | In distribution | |
| REF.U3L1 | In distribution | |
| REF.R4SC2 | In distribution | |
| REF.V8L3 | In distribution | |
| REF.N6A4 | In distribution | |
| REF.F4ZC4 | In distribution | |
| REF.K6D3 | In distribution | |
| REF.H6A1 | In distribution | |
| REF.F4SB3 | In distribution | |
| REF.W3D3 | In distribution | |
| REF.U3B1 | In distribution | |
| REF.R2ZC3 | In distribution | |
| REF.W3C2 | In distribution | |
| REF.F2ZC1 | In distribution | |
| REF.M3L1 | In distribution | |
| REF.K4D3 | In distribution | |
| REF.U6L3 | In distribution | |
| REF.M4A3 | In distribution | |
| REF.W3A4 | In distribution | |
| REF.R6ZA3 | In distribution | |
| REF.K6C1 | In distribution | |
| REF.W6B4 | In distribution | |
| REF.V6D3 | In distribution | |
| REF.F4SC1 | In distribution | |
| REF.M1C2 | In distribution | |
| REF.R2SA2 | In distribution | |
| REF.Q1SD3 | In distribution | |
| REF.N4A3 | In distribution | |
| REF.N3L3 | In distribution | |
| REF.N4C1 | In distribution | |
| REF.V8A1 | In distribution | |
| REF.M4L3 | In distribution | |
| REF.R6ZD2 | In distribution | |
| REF.W6C4 | In distribution | |
| REF.F4SD4 | In distribution | |
| REF.V3B4 | In distribution | |
| REF.N4L1 | In distribution | |
| REF.W4C1 | In distribution | |
| REF.F4ZC1 | In distribution | |
| REF.W3C3 | In distribution | |
| REF.Q3ZC2 | In distribution | |
| REF.F4ZA4 | In distribution | |
| REF.F4ZB1 | In distribution | |
| REF.M1A4 | In distribution | |
| REF.V4D4 | In distribution | |
| REF.V1D4 | In distribution | |
| REF.F4ZB3 | In distribution | |
| REF.K4D2 | In distribution | |
| REF.M1D3 | In distribution | |
| REF.Q5SL1 | In distribution | |
| REF.V3D4 | In distribution | |
| REF.Q5ZC4 | In distribution | |
| REF.K4C3 | In distribution | |
| REF.Q5ZD3 | In distribution | |
| REF.V1B3 | In distribution | |
| REF.Q5SA4 | In distribution | |
| REF.H6A9 | In distribution | |
| REF.F4ZD4 | In distribution | |
| REF.F6ZD2 | In distribution | |
| REF.U4D4 | In distribution | |
| REF.R2SB4 | In distribution | |
| REF.V8B3 | In distribution | |
| REF.M4A2 | In distribution | |
| REF.Q1SD2 | In distribution | |
| REF.K6L3 | In distribution | |
| REF.Q1SA4 | In distribution | |
| REF.M1D4 | In distribution | |
| REF.Q5SC3 | In distribution | |
| REF.F6ZA2 | In distribution | |
| REF.N6C1 | In distribution | |
| REF.W6A2 | In distribution | |
| REF.R4ZB1 | In distribution | |
| REF.F2SL3 | In distribution | |
| REF.N4D3 | In distribution | |
| REF.Q3SC2 | In distribution | |
| REF.K4B4 | In distribution | |
| REF.Q1ZL1 | In distribution | |
| REF.Q5ZA1 | In distribution | |
| REF.W6L3 | In distribution | |
| REF.R2ZD2 | In distribution | |
| REF.K3A3 | In distribution | |
| REF.U3C1 | In distribution | |
| REF.Q1SC4 | In distribution | |
| REF.R6SD2 | In distribution | |
| REF.F2ZB1 | In distribution | |
| REF.F4SA9 | In distribution | |
| REF.M3D4 | In distribution | |
| REF.R4ZA3 | In distribution | |
| REF.M6A1 | In distribution | |
| REF.N4B1 | In distribution | |
| REF.R6SD4 | In distribution | |
| REF.H4A3 | In distribution | |
| REF.U6A4 | In distribution | |
| REF.R4ZD2 | In distribution | |
| REF.Q5SD2 | In distribution | |
| REF.R6SC2 | In distribution | |
| REF.Q3ZC1 | In distribution | |
| REF.H3A1 | In distribution | |
| REF.W6C2 | In distribution | |
| REF.N3A2 | In distribution | |
| REF.N6B1 | In distribution | |
| REF.M4C1 | In distribution | |
| REF.V1L1 | In distribution | |
| REF.R6ZC2 | In distribution | |
| REF.R4SL3 | In distribution | |
| REF.F4SB2 | In distribution | |
| REF.Q3ZD3 | In distribution | |
| REF.R6SA9 | In distribution | |
| REF.V8A3 | In distribution | |
| REF.V6B3 | In distribution | |
| REF.N6L1 | In distribution | |
| REF.F4ZA1 | In distribution | |
| REF.R2ZA2 | In distribution | |
| REF.Q3SC4 | In distribution | |
| REF.F4SB4 | In distribution | |
| REF.N4A1 | In distribution | |
| REF.Q3ZB4 | In distribution | |
| REF.R2ZA1 | In distribution | |
| REF.F2ZL1 | In distribution | |
| REF.Q5ZL1 | In distribution | |
| REF.R6SL3 | In distribution | |
| REF.V3C1 | In distribution | |
| REF.K4B3 | In distribution | |
| REF.K4A3 | In distribution | |
| REF.M3D2 | In distribution | |
| REF.V6C1 | In distribution | |
| REF.V1C3 | In distribution | |
| REF.R6SL1 | In distribution | |
| REF.Q1ZA1 | In distribution | |
| REF.R6ZB3 | In distribution | |
| REF.F4SC2 | In distribution | |
| REF.N6A1 | In distribution | |
| REF.M3A9 | In distribution | |
| REF.V1B2 | In distribution | |
| REF.N6D4 | In distribution | |
| REF.V6A2 | In distribution | |
| REF.N6A9 | In distribution | |
| REF.F4ZA2 | In distribution | |
| REF.V3D2 | In distribution | |
| REF.R4ZC2 | In distribution | |
| REF.Q1ZB2 | In distribution | |
| REF.W4D3 | In distribution | |
| REF.F4SD2 | In distribution | |
| REF.U3A9 | In distribution | |
| REF.U3B4 | In distribution | |
| REF.Q5ZC1 | In distribution | |
| REF.V4A9 | In distribution | |
| REF.F6ZB1 | In distribution | |
| REF.W6D3 | In distribution | |
| REF.V8D4 | In distribution | |
| REF.Q1SA2 | In distribution | |
| REF.F6SL1 | In distribution | |
| REF.Q3SL3 | In distribution | |
| REF.W3A3 | In distribution | |
| REF.V1D2 | In distribution | |
| REF.K6B1 | In distribution | |
| REF.R2SB3 | In distribution | |
| REF.V3A9 | In distribution | |
| REF.F6ZB2 | In distribution | |
| REF.V1B1 | In distribution | |
| REF.R6SA2 | In distribution | |
| REF.M3B4 | In distribution | |
| REF.K3A4 | In distribution | |
| REF.N3A9 | In distribution | |
| REF.V6C4 | In distribution | |
| REF.W4D4 | In distribution | |
| REF.K6A3 | In distribution | |
| REF.M3A4 | In distribution | |
| REF.N4C3 | In distribution | |
| REF.R4ZD3 | In distribution | |
| REF.V6A1 | In distribution | |
| REF.K3L3 | In distribution | |
| REF.W3D2 | In distribution | |
| REF.W4B3 | In distribution | |
| REF.U3C3 | In distribution | |
| REF.V4L1 | In distribution | |
| REF.F2SD2 | In distribution | |
| REF.R2ZA4 | In distribution | |
| REF.K3D3 | In distribution | |
| REF.U6B3 | In distribution | |
| REF.M4C3 | In distribution | |
| REF.N3B4 | In distribution | |
| REF.F4SD3 | In distribution | |
| REF.V4B2 | In distribution | |
| REF.M6A3 | In distribution | |
| REF.F6SB2 | In distribution | |
| REF.U6A2 | In distribution | |
| REF.K4A1 | In distribution | |
| REF.M1A2 | In distribution | |
| REF.F2SB2 | In distribution | |
| REF.R2ZB2 | In distribution | |
| REF.U4B4 | In distribution | |
| REF.U4C3 | In distribution | |
| REF.R2ZC2 | In distribution | |
| REF.M1D2 | In distribution | |
| REF.F6SB1 | In distribution | |
| REF.R4SB1 | In distribution | |
| REF.F6SD4 | In distribution | |
| REF.M4A9 | In distribution | |
| REF.R6ZC1 | In distribution | |
| REF.F2ZC2 | In distribution | |
| REF.R4SD4 | In distribution | |
| REF.H3A9 | In distribution | |
| REF.N4D2 | In distribution | |
| REF.V8L1 | In distribution | |
| REF.Q5SD3 | In distribution | |
| REF.Q5SC4 | 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 |
| 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.