Monarch
760 catalogue numbers from Anterior L7 Lower B3, listed by Wright Medical Technology, Inc., United States, under Denture, Plastic, Teeth. 26 manufacturers in China are registered for this product code.
26manufacturers in China registered for this device type
760catalogue numbers in this listing
1510(k) clearance
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 | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Anterior L7 Lower B3 | In distribution | |
| Anterior 21 Upper A3 | In distribution | |
| Anterior L7 Lower A1 | In distribution | |
| Anterior L8 Lower D3 | In distribution | |
| Posterior R5 Lower D2 | In distribution | |
| Anterior 72 Upper D4 | In distribution | |
| Posterior P3 Upper D3 | In distribution | |
| Posterior R2 Lower A4 | In distribution | |
| Anterior L5 Lower D4 | In distribution | |
| Anterior 41 Upper D2 | In distribution | |
| Anterior 53 Upper D3 | In distribution | |
| Anterior L1 Lower D3 | In distribution | |
| Anterior L7 Lower D2 | In distribution | |
| Anterior 20 Upper A2 | In distribution | |
| Anterior 43 Upper D2 | In distribution | |
| Anterior 44 Upper B4 | In distribution | |
| Anterior 43 Upper B3 | In distribution | |
| Anterior L2 Lower D2 | In distribution | |
| Anterior 33 Upper A2 | In distribution | |
| Anterior 52 Upper A1 | In distribution | |
| Anterior 51 Upper A1 | In distribution | |
| Anterior L1 Lower D2 | In distribution | |
| Anterior L2 Lower C2 | In distribution | |
| Posterior P2 Lower A4 | In distribution | |
| Posterior P1 Upper B2 | In distribution | |
| Anterior 40 Upper D3 | In distribution | |
| Posterior R2 Upper D4 | In distribution | |
| Anterior 22 Upper D3 | In distribution | |
| Posterior P4 Lower A1 | In distribution | |
| Anterior L9 Lower C3 | In distribution | |
| Posterior P2 Upper D4 | In distribution | |
| Anterior 20 Upper A4 | In distribution | |
| Anterior 72 Upper B2 | In distribution | |
| Anterior 23 Upper C4 | In distribution | |
| Anterior 71 Upper C1 | In distribution | |
| Anterior L1 Lower D4 | In distribution | |
| Posterior R4 Lower C4 | In distribution | |
| Posterior P3 Upper A3.5 | In distribution | |
| Anterior L6 Lower D3 | In distribution | |
| Anterior 33 Upper A3.5 | In distribution | |
| Anterior 20 Upper B3 | In distribution | |
| Anterior 22 Upper C2 | In distribution | |
| Anterior 50 Upper C3 | In distribution | |
| Anterior 40 Upper B2 | In distribution | |
| Posterior R5 Upper A2 | In distribution | |
| Anterior 43 Upper C4 | In distribution | |
| Anterior L3 Lower B4 | In distribution | |
| Anterior 52 Upper A4 | In distribution | |
| Anterior L3 Lower A2 | In distribution | |
| Posterior P1 Lower C3 | In distribution | |
| Anterior L4 Lower A2 | In distribution | |
| Posterior R3 Upper C1 | In distribution | |
| Anterior 51 Upper A4 | In distribution | |
| Anterior 21 Upper C1 | In distribution | |
| Anterior 21 Upper C4 | In distribution | |
| Anterior 71 Upper B2 | In distribution | |
| Anterior 44 Upper A3.5 | In distribution | |
| Posterior P2 Upper A2 | In distribution | |
| Posterior P3 Upper C4 | In distribution | |
| Posterior P4 Lower D4 | In distribution | |
| Anterior 73 Upper B4 | In distribution | |
| Anterior 30 Upper A1 | In distribution | |
| Anterior 22 Upper C3 | In distribution | |
| Posterior R2 Upper A3.5 | In distribution | |
| Anterior 60 Upper B2 | In distribution | |
| Posterior R2 Upper A4 | In distribution | |
| Anterior 41 Upper B3 | In distribution | |
| Anterior 43 Upper B2 | In distribution | |
| Anterior 71 Upper D2 | In distribution | |
| Posterior R4 Lower D4 | In distribution | |
| Anterior 44 Upper A4 | In distribution | |
| Posterior R4 Lower B3 | In distribution | |
| Anterior L5 Lower C4 | In distribution | |
| Posterior R5 Lower A2 | In distribution | |
| Anterior 51 Upper D3 | In distribution | |
| Anterior L8 Lower C2 | In distribution | |
| Anterior 44 Upper D3 | In distribution | |
| Anterior 23 Upper B3 | In distribution | |
| Anterior 71 Upper A2 | In distribution | |
| Anterior 32 Upper A3 | In distribution | |
| Anterior 21 Upper B4 | In distribution | |
| Anterior 62 Upper A3 | In distribution | |
| Posterior R4 Lower A3 | In distribution | |
| Anterior 42 Upper D3 | In distribution | |
| Posterior P4 Lower A3.5 | In distribution | |
| Posterior P2 Upper A1 | In distribution | |
| Anterior 51 Upper C1 | In distribution | |
| Anterior L8 Lower A4 | In distribution | |
| Anterior 30 Upper A3.5 | In distribution | |
| Anterior 52 Upper D4 | In distribution | |
| Anterior L3 Lower C4 | In distribution | |
| Anterior L8 Lower A3.5 | In distribution | |
| Posterior P4 Upper C1 | In distribution | |
| Anterior 42 Upper A3 | In distribution | |
| Anterior 51 Upper D4 | In distribution | |
| Anterior 70 Upper C1 | In distribution | |
| Anterior 70 Upper C4 | In distribution | |
| Anterior 21 Upper B2 | In distribution | |
| Anterior 33 Upper A4 | In distribution | |
| Anterior 42 Upper A4 | In distribution | |
| Anterior 30 Upper C1 | In distribution | |
| Anterior L5 Lower C3 | In distribution | |
| Anterior L3 Lower D4 | In distribution | |
| Anterior L9 Lower D3 | In distribution | |
| Posterior R4 Upper D4 | In distribution | |
| Anterior 44 Upper B2 | In distribution | |
| Anterior 50 Upper C4 | In distribution | |
| Anterior 73 Upper C2 | In distribution | |
| Posterior P3 Lower B4 | In distribution | |
| Posterior P2 Lower C3 | In distribution | |
| Posterior P3 Lower A1 | In distribution | |
| Posterior P3 Upper D4 | In distribution | |
| Anterior 61 Upper A3 | In distribution | |
| Anterior 70 Upper A3.5 | In distribution | |
| Anterior 51 Upper B4 | In distribution | |
| Anterior 42 Upper B2 | In distribution | |
| Anterior 53 Upper A4 | In distribution | |
| Posterior R2 Upper B3 | In distribution | |
| Anterior 31 Upper D3 | In distribution | |
| Anterior L10 Lower a3.5 | In distribution | |
| Posterior P4 Upper B3 | In distribution | |
| Posterior P3 Upper A1 | In distribution | |
| Anterior 43 Upper C2 | In distribution | |
| Anterior 50 Upper C2 | In distribution | |
| Posterior P2 Lower D3 | In distribution | |
| Anterior L5 Lower B2 | In distribution | |
| Posterior P1 Upper A1 | In distribution | |
| Posterior P2 Upper D2 | In distribution | |
| Posterior R5 Lower D4 | In distribution | |
| Anterior L5 Lower C1 | In distribution | |
| Anterior 30 Upper D3 | In distribution | |
| Anterior L9 Lower A2 | In distribution | |
| Anterior 40 Upper B3 | In distribution | |
| Posterior P4 Upper D4 | In distribution | |
| Posterior R3 Upper A3 | In distribution | |
| Anterior 60 Upper A4 | In distribution | |
| Anterior 73 Upper A3 | In distribution | |
| Anterior 43 Upper A2 | In distribution | |
| Anterior L10 Lower B3 | In distribution | |
| Anterior 40 Upper C2 | In distribution | |
| Anterior 50 Upper D2 | In distribution | |
| Anterior 53 Upper C3 | In distribution | |
| Posterior P1 Upper D2 | In distribution | |
| Posterior R4 Upper C2 | In distribution | |
| Posterior P4 Lower A3 | In distribution | |
| Posterior P1 Upper A3.5 | In distribution | |
| Posterior P2 Upper B2 | In distribution | |
| Anterior 41 Upper B4 | In distribution | |
| Posterior R3 Upper C2 | In distribution | |
| Anterior L8 Lower C4 | In distribution | |
| Anterior L1 Lower A4 | In distribution | |
| Anterior 33 Upper A3 | In distribution | |
| Anterior 50 Upper A3 | In distribution | |
| Anterior 50 Upper A4 | In distribution | |
| Anterior 71 Upper A1 | In distribution | |
| Posterior R5 Lower A1 | In distribution | |
| Anterior 30 Upper A4 | In distribution | |
| Anterior L3 Lower D2 | In distribution | |
| Anterior L10 Lower A1 | In distribution | |
| Anterior 31 Upper D4 | In distribution | |
| Posterior R3 Upper B3 | In distribution | |
| Anterior 31 Upper A2 | In distribution | |
| Anterior 44 Upper A3 | In distribution | |
| Anterior 30 Upper B3 | In distribution | |
| Anterior 20 Upper B2 | In distribution | |
| Anterior 22 Upper D2 | In distribution | |
| Anterior 52 Upper C2 | In distribution | |
| Anterior L10 Lower B4 | In distribution | |
| Anterior 40 Upper A4 | In distribution | |
| Anterior 32 Upper A1 | In distribution | |
| Anterior 72 Upper B3 | In distribution | |
| Anterior L6 Lower B4 | In distribution | |
| Anterior L2 Lower C1 | In distribution | |
| Anterior 22 Upper B3 | In distribution | |
| Anterior 31 Upper C3 | In distribution | |
| Anterior 43 Upper B4 | In distribution | |
| Anterior 40 Upper A3.5 | In distribution | |
| Anterior 21 Upper A1 | In distribution | |
| Posterior P3 Lower A3.5 | In distribution | |
| Posterior R3 Lower A2 | In distribution | |
| Posterior R4 Upper C4 | In distribution | |
| Posterior P4 Upper B2 | In distribution | |
| Anterior 20 Upper A3 | In distribution | |
| Anterior 44 Upper B3 | In distribution | |
| Posterior P4 Upper A1 | In distribution | |
| Anterior 53 Upper C1 | In distribution | |
| Anterior 43 Upper A1 | In distribution | |
| Anterior L3 Lower A1 | In distribution | |
| Posterior P1 Lower C1 | In distribution | |
| Anterior L6 Lower C1 | In distribution | |
| Posterior R3 Upper A4 | In distribution | |
| Anterior L10 Lower A2 | In distribution | |
| Anterior 42 Upper A1 | In distribution | |
| Anterior L2 Lower A4 | In distribution | |
| Posterior R2 Upper D3 | In distribution | |
| Anterior 22 Upper C4 | In distribution | |
| Posterior R5 Lower A3.5 | In distribution | |
| Posterior R4 Upper B3 | In distribution | |
| Anterior 51 Upper C3 | In distribution | |
| Anterior L1 Lower A1 | In distribution | |
| Anterior 61 Upper D3 | In distribution | |
| Anterior 53 Upper B3 | In distribution | |
| Anterior 21 Upper C2 | In distribution | |
| Anterior 50 Upper B2 | In distribution | |
| Anterior L1 Lower A3 | In distribution | |
| Anterior L4 Lower D2 | In distribution | |
| Posterior R3 Lower B3 | In distribution | |
| Anterior 33 Upper B2 | In distribution | |
| Anterior 62 Upper A2 | In distribution | |
| Anterior 73 Upper C1 | In distribution | |
| Anterior 73 Upper B2 | In distribution | |
| Posterior P2 Upper C2 | In distribution | |
| Anterior 20 Upper B4 | In distribution | |
| Posterior R3 Lower D3 | In distribution | |
| Anterior L3 Lower C3 | In distribution | |
| Anterior 73 Upper A2 | In distribution | |
| Anterior 41 Upper D4 | In distribution | |
| Anterior L3 Lower C1 | In distribution | |
| Anterior 44 Upper D2 | In distribution | |
| Anterior 31 Upper C4 | In distribution | |
| Posterior R5 Upper C2 | In distribution | |
| Anterior L6 Lower A3.5 | In distribution | |
| Anterior L6 Lower B3 | In distribution | |
| Anterior L3 Lower A3 | In distribution | |
| Posterior R5 Lower C3 | In distribution | |
| Anterior 72 Upper A3 | In distribution | |
| Posterior R3 Upper B4 | In distribution | |
| Anterior 62 Upper D2 | In distribution | |
| Posterior P4 Lower B3 | In distribution | |
| Anterior L9 Lower A4 | In distribution | |
| Anterior 71 Upper C4 | In distribution | |
| Posterior P1 Lower A3.5 | In distribution | |
| Anterior 20 Upper A3.5 | In distribution | |
| Anterior 73 Upper A3.5 | In distribution | |
| Posterior P4 Lower C4 | In distribution | |
| Anterior L8 Lower C1 | In distribution | |
| Posterior P2 Lower A3 | In distribution | |
| Anterior 40 Upper A3 | In distribution | |
| Posterior P4 Upper D2 | In distribution | |
| Anterior 60 Upper D2 | In distribution | |
| Anterior L9 Lower C4 | In distribution | |
| Anterior 42 Upper D2 | In distribution | |
| Posterior P2 Lower C2 | In distribution | |
| Anterior L8 Lower D4 | In distribution | |
| Anterior 42 Upper C2 | In distribution | |
| Anterior 70 Upper D2 | In distribution | |
| Anterior L4 Lower A4 | In distribution | |
| Anterior 31 Upper C2 | In distribution | |
| Anterior 60 Upper C4 | In distribution | |
| Anterior 30 Upper C2 | 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 |
|---|---|
| K122955 | 2013-03-01 |
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.