Resin Teeth S PE S DCL
SR Vivodent S DCL 6er O A13 A3, SR Vivodent S DCL 6er O A12 A3, SR Vivodent S DCL 6er O A66 A3, SR Vivodent S DCL 6er U A5 A3, SR Vivodent S DCL 6er U A6 A3, SR Vivodent S DCL 6er U A7 A3,…
SR Vivodent S DCL 6er O A13 A3, SR Vivodent S DCL 6er O A12 A3, SR Vivodent S DCL 6er O A66 A3, SR Vivodent S DCL 6er U A5 A3, SR Vivodent S DCL 6er U A6 A3, SR Vivodent S DCL 6er U A7 A3, SR Orthotyp S DCL 8er O N3U A3, SR Orthotyp S DCL 8er U N3L A3, SR Orthotyp S DCL 8er O N4U A3, SR Orthotyp S DCL 8er U N4L A3, SR Orthotyp S DCL 8er O N5U A3, SR Orthotyp S DCL 8er U N5L A3
26manufacturers in China registered for this device type
2,870catalogue numbers in this listing
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 | Ivoclar Vivadent Aktiengesellschaft |
|---|---|
| FDA product code | ELM |
| Device type | Denture, Plastic, Teeth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Premarket notification | Exempt |
| Record published | 2019-01-28 |
| Record revised | 2021-01-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 683613 | In distribution | |
| 683645 | In distribution | |
| 565751 | In distribution | |
| 683661 | In distribution | |
| 685524 | In distribution | |
| 657246 | In distribution | |
| 565644 | In distribution | |
| 656701 | In distribution | |
| 683640 | In distribution | |
| 693752 | In distribution | |
| 683836 | In distribution | |
| 656900 | In distribution | |
| 657055 | In distribution | |
| 657092 | In distribution | |
| 657163 | In distribution | |
| 683407 | In distribution | |
| 683506 | In distribution | |
| 683417 | In distribution | |
| 565740 | In distribution | |
| 657270 | In distribution | |
| 683755 | In distribution | |
| 657057 | In distribution | |
| 693682 | In distribution | |
| 683656 | In distribution | |
| 656777 | In distribution | |
| 657067 | In distribution | |
| 657152 | In distribution | |
| 683607 | In distribution | |
| 683683 | In distribution | |
| 657380 | In distribution | |
| 565900 | In distribution | |
| 656620 | In distribution | |
| 683431 | In distribution | |
| 565672 | In distribution | |
| 657364 | In distribution | |
| 683504 | In distribution | |
| 683527 | In distribution | |
| 687166 | In distribution | |
| 656610 | In distribution | |
| 693677 | In distribution | |
| 683893 | In distribution | |
| 656998 | In distribution | |
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| 565862 | In distribution | |
| 565602 | In distribution | |
| 683945 | In distribution | |
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| 656927 | In distribution | |
| 656898 | In distribution | |
| 683708 | In distribution | |
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| 683481 | In distribution | |
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| 683533 | In distribution | |
| 683444 | In distribution | |
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| 685536 | In distribution | |
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| 683413 | In distribution | |
| 656687 | In distribution | |
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| 683553 | In distribution | |
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| 683692 | In distribution | |
| 693731 | In distribution | |
| 685511 | In distribution | |
| 683424 | In distribution | |
| 683513 | In distribution | |
| 657131 | In distribution | |
| 656798 | In distribution | |
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| 565844 | In distribution | |
| 683682 | In distribution | |
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| 685540 | In distribution | |
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| 683411 | In distribution | |
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| 683501 | In distribution | |
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| 565873 | In distribution | |
| 683935 | In distribution | |
| 683490 | In distribution | |
| 683546 | In distribution | |
| 656733 | In distribution | |
| 683487 | In distribution | |
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| 656778 | In distribution | |
| 657069 | In distribution | |
| 683755 | In distribution | |
| 656594 | In distribution | |
| 683553 | In distribution | |
| 657270 | In distribution | |
| 657146 | In distribution | |
| 685566 | In distribution | |
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| 657167 | In distribution | |
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| 687168 | In distribution | |
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| 683702 | In distribution | |
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| 683954 | In distribution | |
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| 683624 | In distribution | |
| 683626 | In distribution | |
| 657053 | In distribution | |
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| 683554 | In distribution | |
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| 565812 | In distribution | |
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| 685541 | In distribution | |
| 657164 | In distribution | |
| 693709 | In distribution | |
| 565827 | In distribution | |
| 683463 | In distribution | |
| 656772 | In distribution | |
| 683427 | In distribution | |
| 657391 | In distribution | |
| 565598 | In distribution | |
| 656707 | In distribution | |
| 657085 | In distribution | |
| 657247 | In distribution | |
| 656700 | In distribution | |
| 612636 | In distribution | |
| 687173 | In distribution | |
| 683942 | In distribution | |
| 565761 | In distribution | |
| 565736 | In distribution | |
| 656618 | 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 |
| 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 |
| SR Phonares II | Ivoclar Vivadent Aktiengesellschaft | 1,441 |
Showing 12 of 9,979. All products under Denture, Plastic, Teeth
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.