Artegral Life HD
artegral life HighDefinition posterior upper -MADE IN GERMANY-; shade A3.5; mould XS
26manufacturers in China registered for this device type
180catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Merz Dental Gmbh, Germany |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-01 |
| Record revised | 2025-01-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| artegral life HD SZ B1 SO | In distribution | |
| artegral life HD SZ D2 SU | In distribution | |
| artegral life HD SZ B4 SU | In distribution | |
| artegral life HD SZ D3 LO | In distribution | |
| artegral life HD SZ A1 SU | In distribution | |
| artegral life HD SZ D2 XSO | In distribution | |
| artegral life HD SZ A3 XSU | In distribution | |
| artegral life HD SZ C2 LU | In distribution | |
| artegral life HD SZ C2 SU | In distribution | |
| artegral life HD SZ A1 LU | In distribution | |
| artegral life HD SZ BL4 XSU | In distribution | |
| artegral life HD SZ B2 MO | In distribution | |
| artegral life HD SZ A4 MU | In distribution | |
| artegral life HD SZ C1 XSO | In distribution | |
| artegral life HD SZ D4 SU | In distribution | |
| artegral life HD SZ A3 SU | In distribution | |
| artegral life HD SZ B4 LU | In distribution | |
| artegral life HD SZ D2 XLO | In distribution | |
| artegral life HD SZ B1 XLO | In distribution | |
| artegral life HD SZ BL1 XLU | In distribution | |
| artegral life HD SZ C1 XLO | In distribution | |
| artegral life HD SZ C1 MO | In distribution | |
| artegral life HD SZ D2 LU | In distribution | |
| artegral life HD SZ BL4 MU | In distribution | |
| artegral life HD SZ C3 XLO | In distribution | |
| artegral life HD SZ C3 SO | In distribution | |
| artegral life HD SZ A3 MO | In distribution | |
| artegral life HD SZ B2 SO | In distribution | |
| artegral life HD SZ BL1 LO | In distribution | |
| artegral life HD SZ C4 SU | In distribution | |
| artegral life HD SZ B2 LO | In distribution | |
| artegral life HD SZ A2 XSO | In distribution | |
| artegral life HD SZ C2 SO | In distribution | |
| artegral life HD SZ B2 XLO | In distribution | |
| artegral life HD SZ A4 LU | In distribution | |
| artegral life HD SZ C4 MO | In distribution | |
| artegral life HD SZ C4 LO | In distribution | |
| artegral life HD SZ A1 MO | In distribution | |
| artegral life HD SZ BL4 SU | In distribution | |
| artegral life HD SZ A1 SO | In distribution | |
| artegral life HD SZ A3.5 XSO | In distribution | |
| artegral life HD SZ B3 XLO | In distribution | |
| artegral life HD SZ A3.5 SU | In distribution | |
| artegral life HD SZ B2 MU | In distribution | |
| artegral life HD SZ D3 SO | In distribution | |
| artegral life HD SZ BL1 LU | In distribution | |
| artegral life HD SZ C4 LU | In distribution | |
| artegral life HD SZ A2 MO | In distribution | |
| artegral life HD SZ B2 XSO | In distribution | |
| artegral life HD SZ C3 XLU | In distribution | |
| artegral life HD SZ A3 XLO | In distribution | |
| artegral life HD SZ B4 SO | In distribution | |
| artegral life HD SZ D3 MU | In distribution | |
| artegral life HD SZ C2 MU | In distribution | |
| artegral life HD SZ A2 SU | In distribution | |
| artegral life HD SZ BL4 LO | In distribution | |
| artegral life HD SZ B4 XLU | In distribution | |
| artegral life HD SZ C1 XSU | In distribution | |
| artegral life HD SZ B3 SO | In distribution | |
| artegral life HD SZ D3 XLU | In distribution | |
| artegral life HD SZ A1 LO | In distribution | |
| artegral life HD SZ D3 MO | In distribution | |
| artegral life HD SZ C3 XSO | In distribution | |
| artegral life HD SZ B4 MU | In distribution | |
| artegral life HD SZ B1 XLU | In distribution | |
| artegral life HD SZ A4 MO | In distribution | |
| artegral life HD SZ A1 XSU | In distribution | |
| artegral life HD SZ B3 SU | In distribution | |
| artegral life HD SZ A3 LU | In distribution | |
| artegral life HD SZ C1 XLU | In distribution | |
| artegral life HD SZ C1 LO | In distribution | |
| artegral life HD SZ B1 XSO | In distribution | |
| artegral life HD SZ A3 XLU | In distribution | |
| artegral life HD SZ B1 MO | In distribution | |
| artegral life HD SZ B1 SU | In distribution | |
| artegral life HD SZ BL1 MO | In distribution | |
| artegral life HD SZ A4 LO | In distribution | |
| artegral life HD SZ B4 XSO | In distribution | |
| artegral life HD SZ D2 MO | In distribution | |
| artegral life HD SZ C3 MO | In distribution | |
| artegral life HD SZ D4 XLO | In distribution | |
| artegral life HD SZ D2 SO | In distribution | |
| artegral life HD SZ A3.5 MO | In distribution | |
| artegral life HD SZ C3 LO | In distribution | |
| artegral life HD SZ A3.5 MU | In distribution | |
| artegral life HD SZ BL1 XLO | In distribution | |
| artegral life HD SZ C3 XSU | In distribution | |
| artegral life HD SZ D2 XSU | In distribution | |
| artegral life HD SZ A3.5 XLO | In distribution | |
| artegral life HD SZ A3 SO | In distribution | |
| artegral life HD SZ BL1 SU | In distribution | |
| artegral life HD SZ BL1 XSU | In distribution | |
| artegral life HD SZ B1 LO | In distribution | |
| artegral life HD SZ A2 MU | In distribution | |
| artegral life HD SZ A4 XLO | In distribution | |
| artegral life HD SZ C4 XLO | In distribution | |
| artegral life HD SZ C2 LO | In distribution | |
| artegral life HD SZ D2 LO | In distribution | |
| artegral life HD SZ BL4 LU | In distribution | |
| artegral life HD SZ B3 MO | In distribution | |
| artegral life HD SZ D4 MU | In distribution | |
| artegral life HD SZ A4 SO | In distribution | |
| artegral life HD SZ BL4 XLU | In distribution | |
| artegral life HD SZ B2 SU | In distribution | |
| artegral life HD SZ A4 XSO | In distribution | |
| artegral life HD SZ C4 XLU | In distribution | |
| artegral life HD SZ B3 XSU | In distribution | |
| artegral life HD SZ C1 MU | In distribution | |
| artegral life HD SZ D3 XLO | In distribution | |
| artegral life HD SZ A2 XSU | In distribution | |
| artegral life HD SZ BL1 XSO | In distribution | |
| artegral life HD SZ D3 XSO | In distribution | |
| artegral life HD SZ D3 XSU | In distribution | |
| artegral life HD SZ A2 LU | In distribution | |
| artegral life HD SZ C2 MO | In distribution | |
| artegral life HD SZ C2 XLO | In distribution | |
| artegral life HD SZ A2 XLU | In distribution | |
| artegral life HD SZ C4 XSU | In distribution | |
| artegral life HD SZ C1 SO | In distribution | |
| artegral life HD SZ C4 XSO | In distribution | |
| artegral life HD SZ D4 XLU | In distribution | |
| artegral life HD SZ B3 XLU | In distribution | |
| artegral life HD SZ D4 LO | In distribution | |
| artegral life HD SZ A2 LO | In distribution | |
| artegral life HD SZ A4 XLU | In distribution | |
| artegral life HD SZ B1 LU | In distribution | |
| artegral life HD SZ A2 SO | In distribution | |
| artegral life HD SZ A4 XSU | In distribution | |
| artegral life HD SZ BL1 MU | In distribution | |
| artegral life HD SZ C1 LU | In distribution | |
| artegral life HD SZ A3.5 SO | In distribution | |
| artegral life HD SZ B1 MU | In distribution | |
| artegral life HD SZ B2 XSU | In distribution | |
| artegral life HD SZ C1 SU | In distribution | |
| artegral life HD SZ BL4 MO | In distribution | |
| artegral life HD SZ BL4 XSO | In distribution | |
| artegral life HD SZ C2 XLU | In distribution | |
| artegral life HD SZ B3 XSO | In distribution | |
| artegral life HD SZ B2 XLU | In distribution | |
| artegral life HD SZ A1 XSO | In distribution | |
| artegral life HD SZ C3 MU | In distribution | |
| artegral life HD SZ B4 LO | In distribution | |
| artegral life HD SZ C2 XSU | In distribution | |
| artegral life HD SZ A4 SU | In distribution | |
| artegral life HD SZ A1 MU | In distribution | |
| artegral life HD SZ D4 LU | In distribution | |
| artegral life HD SZ D3 SU | In distribution | |
| artegral life HD SZ D4 XSU | In distribution | |
| artegral life HD SZ D4 SO | In distribution | |
| artegral life HD SZ D4 XSO | In distribution | |
| artegral life HD SZ BL1 SO | In distribution | |
| artegral life HD SZ A1 XLO | In distribution | |
| artegral life HD SZ B4 XSU | In distribution | |
| artegral life HD SZ C4 MU | In distribution | |
| artegral life HD SZ A3 LO | In distribution | |
| artegral life HD SZ B4 XLO | In distribution | |
| artegral life HD SZ D2 MU | In distribution | |
| artegral life HD SZ D4 MO | In distribution | |
| artegral life HD SZ A3 MU | In distribution | |
| artegral life HD SZ BL4 XLO | In distribution | |
| artegral life HD SZ D3 LU | In distribution | |
| artegral life HD SZ C4 SO | In distribution | |
| artegral life HD SZ A3.5 LO | In distribution | |
| artegral life HD SZ BL4 SO | In distribution | |
| artegral life HD SZ D2 XLU | In distribution | |
| artegral life HD SZ B3 MU | In distribution | |
| artegral life HD SZ B4 MO | In distribution | |
| artegral life HD SZ B1 XSU | In distribution | |
| artegral life HD SZ A3.5 XLU | In distribution | |
| artegral life HD SZ C3 SU | In distribution | |
| artegral life HD SZ B2 LU | In distribution | |
| artegral life HD SZ B3 LU | In distribution | |
| artegral life HD SZ A3.5 LU | In distribution | |
| artegral life HD SZ A1 XLU | In distribution | |
| artegral life HD SZ A3 XSO | In distribution | |
| artegral life HD SZ A3.5 XSU | In distribution | |
| artegral life HD SZ C3 LU | In distribution | |
| artegral life HD SZ A2 XLO | In distribution | |
| artegral life HD SZ B3 LO | In distribution | |
| artegral life HD SZ C2 XSO | In distribution |
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 |
|---|---|
| K120404 | 2012-05-21 |
| K030588 | 2003-05-07 |
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.