DeltaForm HD
Living mould chart DeltaForm HD in shade A3 containing: 5 upper and 5 lower HD posterior sets
26manufacturers in China registered for this device type
201catalogue 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 | 2021-08-22 |
| 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 |
|---|---|---|
| DeltaForm HD lower posteriors, XL, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size L; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size M; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, S, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size M; upper jaw | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size XS; upper jaw | In distribution | |
| DeltaForm HD upper posteriors, XS, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size M; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, L, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size L; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, L, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size L; upper jaw | In distribution | |
| DeltaForm HD upper posteriors, XS, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size S; upper jaw | In distribution | |
| DeltaForm HD upper posteriors, S, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size M; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size XL; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, S, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, B2 -MADE IN GERMANY- | In distribution | |
| Living mould chart DeltaForm HD A3 | In distribution | |
| DeltaForm HD upper posteriors, XS, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size XS; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size S; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, XL, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size XL; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, S, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size L; upper jaw | In distribution | |
| DeltaForm HD upper posteriors, L, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size S; upper jaw | In distribution | |
| DeltaForm HD upper posteriors, L, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size XS; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, S, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size XL; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, C3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size S; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, D4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size XL; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, M, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size S; upper jaw | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size L; upper jaw | In distribution | |
| DeltaForm HD lower posteriors, S, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size L; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, L, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, A4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size M; upper jaw | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size S; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, XS, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size XL; upper jaw | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size XS; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, XS, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, BL2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, B3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XL, BL4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, A35 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, M, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, C1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, S, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, BL3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, S, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size XL; lower jaw | In distribution | |
| DeltaForm HighDefinition posterior; shade B1; size XS; lower jaw | In distribution | |
| DeltaForm HD upper posteriors, XL, BL1 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, XS, A3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD upper posteriors, L, B2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, L, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A1; size XS; lower jaw | In distribution | |
| DeltaForm HD lower posteriors, L, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XS, C4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, C2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, XL, D2 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, B4 -MADE IN GERMANY- | In distribution | |
| DeltaForm HD lower posteriors, M, D3 -MADE IN GERMANY- | In distribution | |
| DeltaForm HighDefinition posterior; shade A2; size M; lower jaw | 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.