Integral
Living mould chart integral A3 containing: 10 upper and 11 lower anterior sets, 4 upper and 4 lower posteriors sets
26manufacturers in China registered for this device type
581catalogue 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 | 2017-01-21 |
| 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 D4; mould UBL | In distribution | |
| anteriors; shade BL3; mould UBXS | In distribution | |
| anteriors; shade C1; mould UCS | In distribution | |
| anteriors; shade D2; mould UBLL | In distribution | |
| posteriors; shade B4; size M; lower jaw | In distribution | |
| anteriors; shade D2; mould BL | In distribution | |
| posteriors; shade B4; size L; lower jaw | In distribution | |
| anteriors; shade B4; mould BM | In distribution | |
| posteriors; shade B3; size L; lower jaw | In distribution | |
| posteriors; shade BL2; size M; upper jaw | In distribution | |
| anteriors; shade BL4; mould BS | In distribution | |
| anteriors; shade A4; mould UIM | In distribution | |
| anteriors; shade B2; mould BM | In distribution | |
| anteriors; shade A3; mould BXS | In distribution | |
| anteriors; shade A1; mould BL | In distribution | |
| anteriors; shade BL1; mould UBM | In distribution | |
| anteriors; shade A4; mould CL | In distribution | |
| posteriors; shade BL2; size L; lower jaw | In distribution | |
| posteriors; shade BL4; size L; lower jaw | In distribution | |
| anteriors; shade BL1; mould UBS | In distribution | |
| anteriors; shade C2; mould IL | In distribution | |
| anteriors; shade B1; mould BL | In distribution | |
| posteriors; shade D2; size M; upper jaw | In distribution | |
| anteriors; shade BL3; mould BL | In distribution | |
| anteriors; shade D2; mould UCM | In distribution | |
| posteriors; shade C3; size XS; upper jaw | In distribution | |
| anteriors; shade A1; mould UBM | In distribution | |
| posteriors; shade D3; size L; upper jaw | In distribution | |
| anteriors; shade B2; mould CL | In distribution | |
| anteriors; shade A3; mould UIM | In distribution | |
| anteriors; shade A3; mould UCS | In distribution | |
| anteriors; shade C2; mould BXS | In distribution | |
| posteriors; shade B1; size S; lower jaw | In distribution | |
| anteriors; shade B2; mould UCM | In distribution | |
| posteriors; shade B2; size S; upper jaw | In distribution | |
| posteriors; shade C3; size M; lower jaw | In distribution | |
| anteriors; shade A1; mould UCM | In distribution | |
| posteriors; shade BL1; size S; lower jaw | In distribution | |
| anteriors; shade BL3; mould UIS | In distribution | |
| anteriors; shade BL3; mould UBM | In distribution | |
| posteriors; shade C3; size M; upper jaw | In distribution | |
| anteriors; shade D4; mould BM | In distribution | |
| anteriors; shade A4; mould UIS | In distribution | |
| anteriors; shade B3; mould UCM | In distribution | |
| anteriors; shade D4; mould BXS | In distribution | |
| anteriors; shade A2; mould UIM | In distribution | |
| anteriors; shade A3.5; mould CM | In distribution | |
| anteriors; shade C2; mould UBM | In distribution | |
| posteriors; shade C2; size S; lower jaw | In distribution | |
| anteriors; shade BL3; mould UCS | In distribution | |
| anteriors; shade C4; mould BM | In distribution | |
| anteriors; shade BL1; mould CL | In distribution | |
| anteriors; shade A3.5; mould UBM | In distribution | |
| anteriors; shade A1; mould CM | In distribution | |
| Living mould chart integral A3 | In distribution | |
| anteriors; shade B1; mould CL | In distribution | |
| posteriors; shade B1; size M; lower jaw | In distribution | |
| anteriors; shade C1; mould IS | In distribution | |
| anteriors; shade BL3; mould UBL | In distribution | |
| posteriors; shade D2; size S; upper jaw | In distribution | |
| posteriors; shade C3; size L; upper jaw | In distribution | |
| anteriors; shade BL1; mould UCS | In distribution | |
| anteriors; shade A3; mould BM | In distribution | |
| anteriors; shade A3.5; mould UIL | In distribution | |
| anteriors; shade B4; mould UBM | In distribution | |
| posteriors; shade BL2; size M; lower jaw | In distribution | |
| posteriors; shade A1; size L; lower jaw | In distribution | |
| anteriors; shade D4; mould CS | In distribution | |
| anteriors; shade A3; mould BL | In distribution | |
| posteriors; shade A2; size M; lower jaw | In distribution | |
| posteriors; shade C4; size XS; upper jaw | In distribution | |
| anteriors; shade A3; mould UCL | In distribution | |
| posteriors; shade A3; size XS; lower jaw | In distribution | |
| anteriors; shade D2; mould UBXS | In distribution | |
| anteriors; shade A2; mould CM | In distribution | |
| anteriors; shade A4; mould UCM | In distribution | |
| anteriors; shade A3; mould IS | In distribution | |
| anteriors; shade A4; mould UBS | In distribution | |
| anteriors; shade B4; mould CS | In distribution | |
| posteriors; shade C4; size M; lower jaw | In distribution | |
| anteriors; shade A2; mould UCL | In distribution | |
| posteriors; shade A1; size M; lower jaw | In distribution | |
| anteriors; shade C4; mould BXS | In distribution | |
| posteriors; shade BL4; size M; upper jaw | In distribution | |
| anteriors; shade BL3; mould UCM | In distribution | |
| anteriors; shade B3; mould UBS | In distribution | |
| posteriors; shade B2; size XS; upper jaw | In distribution | |
| anteriors; shade BL1; mould BM | In distribution | |
| anteriors; shade D3; mould CS | In distribution | |
| anteriors; shade D3; mould BL | In distribution | |
| anteriors; shade B1; mould BM | In distribution | |
| anteriors; shade BL1; mould UIS | In distribution | |
| anteriors; shade D4; mould UIS | In distribution | |
| anteriors; shade BL3; mould UBLL | In distribution | |
| posteriors; shade BL3; size L; lower jaw | In distribution | |
| posteriors; shade A1; size XS; lower jaw | In distribution | |
| posteriors; shade C1; size S; upper jaw | In distribution | |
| anteriors; shade C1; mould UBM | In distribution | |
| anteriors; shade D4; mould CM | In distribution | |
| posteriors; shade D4; size XS; upper jaw | In distribution | |
| anteriors; shade C2; mould IM | In distribution | |
| anteriors; shade B2; mould UIS | In distribution | |
| anteriors; shade B2; mould CS | In distribution | |
| anteriors; shade BL1; mould UCL | In distribution | |
| posteriors; shade C2; size S; upper jaw | In distribution | |
| anteriors; shade D2; mould IS | In distribution | |
| anteriors; shade A1; mould CL | In distribution | |
| anteriors; shade BL3; mould BM | In distribution | |
| anteriors; shade C4; mould IM | In distribution | |
| posteriors; shade BL3; size XS; lower jaw | In distribution | |
| anteriors; shade B3; mould IM | In distribution | |
| anteriors; shade BL2; mould UBM | In distribution | |
| posteriors; shade C3; size S; lower jaw | In distribution | |
| anteriors; shade B3; mould CS | In distribution | |
| posteriors; shade A3; size S; lower jaw | In distribution | |
| anteriors; shade C2; mould CL | In distribution | |
| anteriors; shade C1; mould UBS | In distribution | |
| anteriors; shade B1; mould UIS | In distribution | |
| anteriors; shade BL2; mould UBL | In distribution | |
| anteriors; shade A2; mould UBLL | In distribution | |
| anteriors; shade B3; mould CM | In distribution | |
| anteriors; shade A1; mould BXS | In distribution | |
| anteriors; shade BL4; mould UBS | In distribution | |
| posteriors; shade B1; size M; upper jaw | In distribution | |
| anteriors; shade BL2; mould UCS | In distribution | |
| anteriors; shade BL1; mould CM | In distribution | |
| anteriors; shade C4; mould UCM | In distribution | |
| anteriors; shade B2; mould UBL | In distribution | |
| anteriors; shade D3; mould CM | In distribution | |
| anteriors; shade BL4; mould UBLL | In distribution | |
| posteriors; shade BL4; size M; lower jaw | In distribution | |
| posteriors; shade A3.5; size XS; upper jaw | In distribution | |
| anteriors; shade D2; mould BS | In distribution | |
| posteriors; shade A2; size L; upper jaw | In distribution | |
| anteriors; shade B1; mould UBLL | In distribution | |
| posteriors; shade A2; size L; lower jaw | In distribution | |
| anteriors; shade A3.5; mould BXS | In distribution | |
| anteriors; shade A2; mould IM | In distribution | |
| anteriors; shade B3; mould UCS | In distribution | |
| posteriors; shade A3; size M; upper jaw | In distribution | |
| posteriors; shade A4; size S; lower jaw | In distribution | |
| anteriors; shade B4; mould UIS | In distribution | |
| anteriors; shade A3; mould BS | In distribution | |
| anteriors; shade A1; mould UIL | In distribution | |
| posteriors; shade B2; size M; lower jaw | In distribution | |
| anteriors; shade C2; mould UIL | In distribution | |
| posteriors; shade D3; size XS; lower jaw | In distribution | |
| anteriors; shade A2; mould UIL | In distribution | |
| anteriors; shade D3; mould BM | In distribution | |
| anteriors; shade A3; mould CS | In distribution | |
| anteriors; shade B3; mould BXS | In distribution | |
| posteriors; shade D2; size S; lower jaw | In distribution | |
| anteriors; shade A4; mould UBLL | In distribution | |
| anteriors; shade C4; mould IL | In distribution | |
| anteriors; shade A2; mould UBL | In distribution | |
| anteriors; shade C1; mould UBL | In distribution | |
| posteriors; shade A2; size S; lower jaw | In distribution | |
| anteriors; shade D4; mould BS | In distribution | |
| posteriors; shade BL1; size M; upper jaw | In distribution | |
| anteriors; shade D3; mould UCL | In distribution | |
| anteriors; shade B2; mould IS | In distribution | |
| posteriors; shade B2; size M; upper jaw | In distribution | |
| anteriors; shade BL4; mould IM | In distribution | |
| posteriors; shade B2; size XS; lower jaw | In distribution | |
| anteriors; shade A3.5; mould UBL | In distribution | |
| anteriors; shade C1; mould UBLL | In distribution | |
| posteriors; shade A2; size M; upper jaw | In distribution | |
| anteriors; shade C3; mould UBLL | In distribution | |
| posteriors; shade BL1; size XS; lower jaw | In distribution | |
| anteriors; shade BL1; mould UCM | In distribution | |
| anteriors; shade A3; mould UBM | In distribution | |
| anteriors; shade D3; mould UCM | In distribution | |
| anteriors; shade D2; mould CS | In distribution | |
| anteriors; shade A4; mould UBM | In distribution | |
| posteriors; shade D3; size S; upper jaw | In distribution | |
| anteriors; shade C2; mould UBS | In distribution | |
| posteriors; shade D3; size S; lower jaw | In distribution | |
| posteriors; shade B4; size XS; upper jaw | In distribution | |
| anteriors; shade C1; mould UBXS | In distribution | |
| anteriors; shade BL2; mould IS | In distribution | |
| anteriors; shade A1; mould UBLL | In distribution | |
| posteriors; shade D4; size S; upper jaw | In distribution | |
| anteriors; shade BL2; mould UCL | In distribution | |
| posteriors; shade C4; size L; upper jaw | In distribution | |
| anteriors; shade BL2; mould UIM | In distribution | |
| anteriors; shade B4; mould UIL | In distribution | |
| anteriors; shade C2; mould UCS | In distribution | |
| anteriors; shade BL1; mould IS | In distribution | |
| posteriors; shade C1; size M; upper jaw | In distribution | |
| anteriors; shade A4; mould CS | In distribution | |
| anteriors; shade C3; mould UBXS | In distribution | |
| posteriors; shade B3; size M; upper jaw | In distribution | |
| anteriors; shade C4; mould CM | In distribution | |
| anteriors; shade C3; mould UCS | In distribution | |
| posteriors; shade B2; size S; lower jaw | In distribution | |
| anteriors; shade C3; mould BS | In distribution | |
| anteriors; shade C2; mould UCL | In distribution | |
| anteriors; shade B4; mould UCM | In distribution | |
| anteriors; shade D3; mould BS | In distribution | |
| anteriors; shade A2; mould BL | In distribution | |
| posteriors; shade BL3; size M; upper jaw | In distribution | |
| anteriors; shade A3; mould IM | In distribution | |
| anteriors; shade B2; mould BS | In distribution | |
| posteriors; shade A3.5; size S; upper jaw | In distribution | |
| posteriors; shade A4; size XS; upper jaw | In distribution | |
| anteriors; shade D3; mould CL | In distribution | |
| posteriors; shade C4; size L; lower jaw | In distribution | |
| anteriors; shade C3; mould UIS | In distribution | |
| anteriors; shade BL4; mould UBL | In distribution | |
| anteriors; shade A1; mould CS | In distribution | |
| anteriors; shade D2; mould UIS | In distribution | |
| anteriors; shade BL4; mould BL | In distribution | |
| anteriors; shade BL2; mould CM | In distribution | |
| posteriors; shade BL3; size S; lower jaw | In distribution | |
| anteriors; shade A1; mould UIM | In distribution | |
| anteriors; shade D3; mould IM | In distribution | |
| anteriors; shade A1; mould UBS | In distribution | |
| anteriors; shade C2; mould IS | In distribution | |
| anteriors; shade BL2; mould UIS | In distribution | |
| anteriors; shade A1; mould UBL | In distribution | |
| anteriors; shade C2; mould UIS | In distribution | |
| anteriors; shade D3; mould UBXS | In distribution | |
| anteriors; shade C1; mould UIL | In distribution | |
| posteriors; shade A3; size L; lower jaw | In distribution | |
| anteriors; shade D2; mould UBS | In distribution | |
| posteriors; shade BL2; size L; upper jaw | In distribution | |
| anteriors; shade BL3; mould CM | In distribution | |
| posteriors; shade B2; size L; upper jaw | In distribution | |
| posteriors; shade BL1; size L; lower jaw | In distribution | |
| anteriors; shade A3.5; mould UIM | In distribution | |
| anteriors; shade BL4; mould IL | In distribution | |
| anteriors; shade A2; mould IS | In distribution | |
| anteriors; shade B4; mould UBXS | In distribution | |
| anteriors; shade A1; mould BS | In distribution | |
| anteriors; shade B2; mould UCS | In distribution | |
| anteriors; shade A4; mould UIL | In distribution | |
| anteriors; shade D3; mould UIL | In distribution | |
| anteriors; shade B3; mould UIL | In distribution | |
| anteriors; shade D4; mould UCS | In distribution | |
| posteriors; shade B3; size L; upper jaw | In distribution | |
| anteriors; shade D2; mould UBM | In distribution | |
| anteriors; shade A3; mould UIL | In distribution | |
| anteriors; shade B2; mould UBM | In distribution | |
| posteriors; shade D3; size L; lower jaw | In distribution | |
| anteriors; shade BL4; mould UIS | In distribution | |
| posteriors; shade BL3; size S; upper jaw | In distribution | |
| anteriors; shade D3; mould UIS | In distribution | |
| anteriors; shade D2; mould BXS | In distribution | |
| anteriors; shade B1; mould UBM | In distribution | |
| anteriors; shade BL1; mould IL | 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.