Artegral
posteriors; shade A3.5 light; size XS; lower jaw
26manufacturers in China registered for this device type
1,075catalogue 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 |
| 510(k) | K030588 |
| Record published | 2016-12-31 |
| Record revised | 2025-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| anteriors; shade A3; mould UBIM | In distribution | |
| anteriors; shade A3; mould IS | In distribution | |
| anteriors; shade A3.5; mould IL | In distribution | |
| anteriors; shade C2; mould IXL | In distribution | |
| anteriors; shade D2 light; mould CS | In distribution | |
| anteriors; shade B3; mould IM | In distribution | |
| posteriors; shade BL3; size XL; lower jaw | In distribution | |
| anteriors; shade C4; mould UBL | In distribution | |
| anteriors; shade B2; mould BIM | In distribution | |
| anteriors; shade C1; mould BM | In distribution | |
| posteriors; shade A4; size XS; upper jaw | In distribution | |
| anteriors; shade A4; mould CM | In distribution | |
| posteriors; shade BL1; size L; upper jaw | In distribution | |
| posteriors; shade D3 light; size L; lower jaw | In distribution | |
| posteriors; shade BL1; size L; lower jaw | In distribution | |
| anteriors; shade A3; mould BOM | In distribution | |
| anteriors; shade C3; mould CL | In distribution | |
| posteriors; shade BL2; size XS; lower jaw | In distribution | |
| anteriors; shade A2 light; mould BIS | In distribution | |
| anteriors; shade D4; mould IM | In distribution | |
| anteriors; shade C3; mould BL | In distribution | |
| posteriors; shade C2; size M; lower jaw | In distribution | |
| anteriors; shade A1; mould BIS | In distribution | |
| anteriors; shade D2; mould UIS | In distribution | |
| posteriors; shade C2; size S; upper jaw | In distribution | |
| anteriors; shade C4; mould UIS | In distribution | |
| posteriors; shade B3; size S; upper jaw | In distribution | |
| anteriors; shade A3.5 light; mould CM | In distribution | |
| anteriors; shade A1; mould UBS | In distribution | |
| anteriors; shade BL2; mould UBM | In distribution | |
| posteriors; shade D2; size S; lower jaw | In distribution | |
| anteriors; shade BL3; mould BL | In distribution | |
| anteriors; shade A2 light; mould UIM | In distribution | |
| anteriors; shade B1; mould BM | In distribution | |
| anteriors; shade BL1; mould ITS | In distribution | |
| anteriors; shade B1; mould BIL | In distribution | |
| posteriors; shade C1; size S; upper jaw | In distribution | |
| posteriors; shade B3; size M; upper jaw | In distribution | |
| anteriors; shade BL1; mould UBIL | In distribution | |
| anteriors; shade A3; mould UBIS | In distribution | |
| anteriors; shade B4; mould UBIM | In distribution | |
| anteriors; shade B1; mould UBIS | In distribution | |
| anteriors; shade A3.5; mould UCM | In distribution | |
| anteriors; shade D2; mould BS | In distribution | |
| anteriors; shade D3 light; mould BIM | In distribution | |
| anteriors; shade B3; mould IXL | In distribution | |
| anteriors; shade A2 light; mould UBM | In distribution | |
| anteriors; shade C1; mould BIS | In distribution | |
| anteriors; shade B1; mould CS | In distribution | |
| anteriors; shade D2; mould BIM | In distribution | |
| anteriors; shade A3 light; mould UBIL | In distribution | |
| anteriors; shade A1; mould UIS | In distribution | |
| posteriors; shade C4; size M; lower jaw | In distribution | |
| anteriors; shade A3.5; mould BS | In distribution | |
| anteriors; shade C3; mould ITM | In distribution | |
| anteriors; shade A4; mould IXL | In distribution | |
| anteriors; shade B4; mould UBS | In distribution | |
| anteriors; shade C3; mould UCM | In distribution | |
| anteriors; shade C4; mould IS | In distribution | |
| anteriors; shade C3; mould UBXL | In distribution | |
| anteriors; shade A3; mould UBM | In distribution | |
| anteriors; shade B1; mould UIM | In distribution | |
| anteriors; shade BL3; mould BOM | In distribution | |
| posteriors; shade D4; size XL; upper jaw | In distribution | |
| anteriors; shade C1; mould BXL | In distribution | |
| anteriors; shade A4; mould BOL | In distribution | |
| anteriors; shade A4; mould CL | In distribution | |
| anteriors; shade A3; mould BIL | In distribution | |
| anteriors; shade BL4; mould UCS | In distribution | |
| anteriors; shade B4; mould BOL | In distribution | |
| anteriors; shade BL1; mould UBXL | In distribution | |
| anteriors; shade B3; mould BOM | In distribution | |
| posteriors; shade B1; size M; upper jaw | In distribution | |
| anteriors; shade C3; mould BS | In distribution | |
| anteriors; shade A3; mould UIS | In distribution | |
| posteriors; shade BL2; size M; lower jaw | In distribution | |
| anteriors; shade D2 light; mould BXL | In distribution | |
| posteriors; shade A3.5 light; size XS; lower jaw | In distribution | |
| posteriors; shade A3.5; size XL; lower jaw | In distribution | |
| anteriors; shade A3; mould CL | In distribution | |
| anteriors; shade A3.5 light; mould UBIL | In distribution | |
| anteriors; shade A3.5; mould CS | In distribution | |
| posteriors; shade B2; size S; upper jaw | In distribution | |
| anteriors; shade B2; mould UCM | In distribution | |
| anteriors; shade BL2; mould UBS | In distribution | |
| anteriors; shade A2; mould ITM | In distribution | |
| anteriors; shade B3; mould BM | In distribution | |
| anteriors; shade D4; mould UBL | In distribution | |
| posteriors; shade A3 light; size XL; lower jaw | In distribution | |
| anteriors; shade A3 light; mould UBS | In distribution | |
| anteriors; shade B2; mould CL | In distribution | |
| anteriors; shade A2 light; mould UIL | In distribution | |
| anteriors; shade BL2; mould BL | In distribution | |
| posteriors; shade BL1; size S; upper jaw | In distribution | |
| anteriors; shade D3 light; mould UCL | In distribution | |
| posteriors; shade D3 light; size XS; upper jaw | In distribution | |
| posteriors; shade A4; size XL; upper jaw | In distribution | |
| anteriors; shade A2 light; mould ITL | In distribution | |
| anteriors; shade B3; mould BXL | In distribution | |
| anteriors; shade C4; mould UBM | In distribution | |
| posteriors; shade D2 light; size M; lower jaw | In distribution | |
| posteriors; shade C3; size XL; upper jaw | In distribution | |
| anteriors; shade C3; mould CS | In distribution | |
| anteriors; shade A3 light; mould UCM | In distribution | |
| anteriors; shade A1; mould BOS | In distribution | |
| anteriors; shade B2; mould BOM | In distribution | |
| anteriors; shade C1; mould CS | In distribution | |
| posteriors; shade A2 light; size S; lower jaw | In distribution | |
| posteriors; shade A3.5; size XS; upper jaw | In distribution | |
| anteriors; shade B3; mould ITM | In distribution | |
| anteriors; shade D3 light; mould IM | In distribution | |
| anteriors; shade BL1; mould UBM | In distribution | |
| anteriors; shade BL3; mould IS | In distribution | |
| posteriors; shade D2 light; size XS; upper jaw | In distribution | |
| anteriors; shade B2; mould UBS | In distribution | |
| anteriors; shade B2; mould ITL | In distribution | |
| anteriors; shade C4; mould BL | In distribution | |
| anteriors; shade D3; mould UIM | In distribution | |
| anteriors; shade A2 light; mould BOM | In distribution | |
| anteriors; shade BL1; mould BOS | In distribution | |
| anteriors; shade BL4; mould BXL | In distribution | |
| anteriors; shade A3.5 light; mould IM | In distribution | |
| anteriors; shade BL3; mould CM | In distribution | |
| anteriors; shade A3; mould UCM | In distribution | |
| anteriors; shade D2; mould UBIL | In distribution | |
| anteriors; shade A3; mould BS | In distribution | |
| anteriors; shade D3 light; mould UBIM | In distribution | |
| posteriors; shade BL4; size XL; upper jaw | In distribution | |
| anteriors; shade C3; mould BIS | In distribution | |
| anteriors; shade A3; mould UBXL1970080 | In distribution | |
| posteriors; shade A3; size M; lower jaw | In distribution | |
| anteriors; shade B2; mould ITS | In distribution | |
| anteriors; shade B3; mould CS | In distribution | |
| anteriors; shade D2; mould CM | In distribution | |
| posteriors; shade B3; size XS; lower jaw | In distribution | |
| anteriors; shade A2 light; mould UBL | In distribution | |
| posteriors; shade B2; size XL; lower jaw | In distribution | |
| anteriors; shade BL1; mould IM | In distribution | |
| anteriors; shade A2; mould BL | In distribution | |
| anteriors; shade A2; mould BOL | In distribution | |
| anteriors; shade D3; mould IS | In distribution | |
| anteriors; shade D2; mould BL | In distribution | |
| anteriors; shade D3 light; mould BOS | In distribution | |
| anteriors; shade BL1; mould UCM | In distribution | |
| anteriors; shade BL4; mould IM | In distribution | |
| anteriors; shade B4; mould UBIS | In distribution | |
| anteriors; shade C2; mould IS | In distribution | |
| anteriors; shade D3 light; mould UIM | In distribution | |
| anteriors; shade A3.5 light; mould CS | In distribution | |
| anteriors; shade A2 light; mould ITM | In distribution | |
| anteriors; shade BL1; mould ITL | In distribution | |
| anteriors; shade A3.5 light; mould ITM | In distribution | |
| anteriors; shade A3.5 light; mould BIL | In distribution | |
| anteriors; shade A3.5 light; mould CL | In distribution | |
| anteriors; shade BL3; mould BIM | In distribution | |
| anteriors; shade A3 light; mould BM | In distribution | |
| anteriors; shade D2 light; mould UBIL | In distribution | |
| anteriors; shade B2; mould BM | In distribution | |
| anteriors; shade A3; mould ITL | In distribution | |
| posteriors; shade B4; size XS; upper jaw | In distribution | |
| posteriors; shade D2 light; size XL; upper jaw | In distribution | |
| anteriors; shade C4; mould CS | In distribution | |
| posteriors; shade A3 light; size M; upper jaw | In distribution | |
| anteriors; shade B1; mould ITS | In distribution | |
| anteriors; shade B2; mould IL | In distribution | |
| anteriors; shade C1; mould BOL | In distribution | |
| anteriors; shade D2 light; mould CL | In distribution | |
| posteriors; shade BL4; size XS; upper jaw | In distribution | |
| anteriors; shade BL4; mould UBIL | In distribution | |
| posteriors; shade A1; size M; lower jaw | In distribution | |
| anteriors; shade C2; mould UBIM | In distribution | |
| anteriors; shade C3; mould UIM | In distribution | |
| anteriors; shade C1; mould CM | In distribution | |
| posteriors; shade A2 light; size S; upper jaw | In distribution | |
| anteriors; shade A3.5; mould IS | In distribution | |
| anteriors; shade A2; mould UBS | In distribution | |
| anteriors; shade B3; mould IL | In distribution | |
| posteriors; shade A2; size M; upper jaw | In distribution | |
| posteriors; shade BL1; size M; upper jaw | In distribution | |
| anteriors; shade D4; mould ITS | In distribution | |
| posteriors; shade A3.5 light; size XS; upper jaw | In distribution | |
| anteriors; shade D3; mould UCL | In distribution | |
| anteriors; shade A1; mould ITS | In distribution | |
| anteriors; shade A2; mould UBXL | In distribution | |
| anteriors; shade A4; mould ITL | In distribution | |
| anteriors; shade B3; mould BIL | In distribution | |
| anteriors; shade BL4; mould UIL | In distribution | |
| posteriors; shade BL4; size S; lower jaw | In distribution | |
| anteriors; shade A3; mould UIM | In distribution | |
| anteriors; shade B1; mould UCS | In distribution | |
| anteriors; shade A3.5 light; mould ITS | In distribution | |
| anteriors; shade D3 light; mould BM | In distribution | |
| anteriors; shade C3; mould BIM | In distribution | |
| posteriors; shade B4; size S; lower jaw | In distribution | |
| anteriors; shade BL3; mould IXL | In distribution | |
| anteriors; shade BL3; mould UCL | In distribution | |
| posteriors; shade BL1; size XL; lower jaw | In distribution | |
| anteriors; shade B4; mould BOM | In distribution | |
| anteriors; shade C1; mould ITL | In distribution | |
| anteriors; shade C4; mould BIL | In distribution | |
| posteriors; shade B1; size XL; upper jaw | In distribution | |
| anteriors; shade B1; mould CM | In distribution | |
| posteriors; shade A1; size XS; lower jaw | In distribution | |
| anteriors; shade A3.5 light; mould UIS | In distribution | |
| anteriors; shade A2; mould BS | In distribution | |
| posteriors; shade D3; size M; lower jaw | In distribution | |
| anteriors; shade A1; mould BOL | In distribution | |
| anteriors; shade D2; mould UCL | In distribution | |
| anteriors; shade A3 light; mould CS | In distribution | |
| anteriors; shade A2 light; mould UCS | In distribution | |
| anteriors; shade C3; mould IL | In distribution | |
| anteriors; shade D3; mould BOL | In distribution | |
| posteriors; shade A3.5; size L; lower jaw | In distribution | |
| anteriors; shade A3.5; mould ITL | In distribution | |
| anteriors; shade BL2; mould IS | In distribution | |
| posteriors; shade A2 light; size XS; lower jaw | In distribution | |
| anteriors; shade A4; mould BM | In distribution | |
| anteriors; shade BL3; mould BOS | In distribution | |
| anteriors; shade A1; mould CL | In distribution | |
| anteriors; shade D2; mould UBM | In distribution | |
| anteriors; shade D4; mould UIL | In distribution | |
| posteriors; shade D3 light; size M; upper jaw | In distribution | |
| anteriors; shade C4; mould BOS | In distribution | |
| anteriors; shade BL2; mould UIL | In distribution | |
| anteriors; shade D2 light; mould IL | In distribution | |
| anteriors; shade D3; mould UBIM | In distribution | |
| anteriors; shade B3; mould CL | In distribution | |
| anteriors; shade D2 light; mould ITS | In distribution | |
| anteriors; shade BL4; mould CM | In distribution | |
| anteriors; shade C2; mould ITL | In distribution | |
| anteriors; shade A1; mould IXL | In distribution | |
| anteriors; shade D2 light; mould UBIS | In distribution | |
| anteriors; shade BL4; mould IL | In distribution | |
| anteriors; shade C3; mould BOL | In distribution | |
| anteriors; shade A3; mould CM | In distribution | |
| posteriors; shade BL3; size M; upper jaw | In distribution | |
| anteriors; shade BL2; mould UIS | In distribution | |
| anteriors; shade BL4; mould ITM | In distribution | |
| anteriors; shade D2; mould UBL | In distribution | |
| posteriors; shade C2; size XL; lower jaw | In distribution | |
| anteriors; shade C4; mould CL | In distribution | |
| anteriors; shade D3; mould UBL | In distribution | |
| anteriors; shade BL1; mould CL | In distribution | |
| posteriors; shade BL1; size M; lower jaw | In distribution | |
| anteriors; shade D3 light; mould IXL | In distribution | |
| anteriors; shade C2; mould CS | In distribution | |
| anteriors; shade C4; mould UBS | In distribution | |
| anteriors; shade A3 light; mould BOL | In distribution | |
| anteriors; shade C2; mould BL | In distribution | |
| anteriors; shade A3 light; mould BOS | 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 |
|---|---|
| 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.