Fascination®
Assortment Fascination® Ceramic Bracket St. Edg. 22 for tooth 15-25,45-35/ For further information please visit our online-shop on our website www.dentaurum.de
52manufacturers in China registered for this device type
220catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K935139 |
| Record published | 2016-09-15 |
| Record revised | 2019-02-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2019-05-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 700-023-34 | Withdrawn | ||
| 700-047-03 | Withdrawn | ||
| 700-021-00 | 10 | Withdrawn | |
| 700-041-01 | 10 | Withdrawn | |
| 700-037-03 | Withdrawn | ||
| 700-046-00 | 10 | Withdrawn | |
| 700-057-00 | Withdrawn | ||
| 700-017-03 | Withdrawn | ||
| 700-048-00 | 10 | Withdrawn | |
| 700-047-00 | 10 | Withdrawn | |
| 700-005-40 | 10 | Withdrawn | |
| 700-029-11 | 10 | Withdrawn | |
| 700-018-04 | Withdrawn | ||
| 700-002-13 | Withdrawn | ||
| 700-057-01 | Withdrawn | ||
| 700-022-04 | Withdrawn | ||
| 700-002-43 | Withdrawn | ||
| 700-015-03 | Withdrawn | ||
| 700-005-14 | Withdrawn | ||
| 700-023-21 | 10 | Withdrawn | |
| 700-066-00 | 10 | Withdrawn | |
| 700-036-01 | 10 | Withdrawn | |
| 700-038-00 | 10 | Withdrawn | |
| 700-055-01 | Withdrawn | ||
| 700-070-00 | Withdrawn | ||
| 700-026-00 | 10 | Withdrawn | |
| 700-061-01 | Withdrawn | ||
| 700-046-03 | Withdrawn | ||
| 700-002-33 | Withdrawn | ||
| 700-005-00 | 10 | Withdrawn | |
| 700-002-11 | 10 | Withdrawn | |
| 700-063-01 | Withdrawn | ||
| 700-043-20 | 10 | Withdrawn | |
| 700-021-03 | Withdrawn | ||
| 700-050-24 | Withdrawn | ||
| 700-049-11 | 10 | Withdrawn | |
| 700-005-10 | 10 | Withdrawn | |
| 700-028-03 | Withdrawn | ||
| 700-006-00 | 10 | Withdrawn | |
| 700-043-11 | 10 | Withdrawn | |
| 700-004-00 | 10 | Withdrawn | |
| 700-021-01 | 10 | Withdrawn | |
| 700-023-23 | Withdrawn | ||
| 700-015-01 | 10 | Withdrawn | |
| 700-038-04 | Withdrawn | ||
| 700-023-24 | Withdrawn | ||
| 700-043-24 | Withdrawn | ||
| 700-036-04 | Withdrawn | ||
| 700-022-01 | 10 | Withdrawn | |
| 700-002-41 | 10 | Withdrawn | |
| 700-043-30 | 10 | Withdrawn | |
| 700-050-11 | 10 | Withdrawn | |
| 700-039-03 | Withdrawn | ||
| 700-005-33 | Withdrawn | ||
| 700-063-00 | Withdrawn | ||
| 700-038-01 | 10 | Withdrawn | |
| 700-050-23 | Withdrawn | ||
| 700-002-20 | 10 | Withdrawn | |
| 700-015-00 | 10 | Withdrawn | |
| 700-062-00 | Withdrawn | ||
| 700-005-43 | Withdrawn | ||
| 700-056-01 | Withdrawn | ||
| 700-037-00 | 10 | Withdrawn | |
| 700-035-04 | Withdrawn | ||
| 700-050-10 | 10 | Withdrawn | |
| 700-060-00 | Withdrawn | ||
| 700-019-03 | Withdrawn | ||
| 700-043-33 | Withdrawn | ||
| 700-022-00 | 10 | Withdrawn | |
| 700-047-01 | 10 | Withdrawn | |
| 700-016-03 | Withdrawn | ||
| 700-001-03 | Withdrawn | ||
| 700-043-21 | 10 | Withdrawn | |
| 700-045-03 | Withdrawn | ||
| 700-035-01 | 10 | Withdrawn | |
| 700-041-04 | Withdrawn | ||
| 700-002-31 | 10 | Withdrawn | |
| 700-043-14 | Withdrawn | ||
| 700-029-20 | 10 | Withdrawn | |
| 700-048-04 | Withdrawn | ||
| 700-066-03 | Withdrawn | ||
| 700-002-14 | Withdrawn | ||
| 700-050-20 | 10 | Withdrawn | |
| 700-065-03 | Withdrawn | ||
| 700-030-24 | Withdrawn | ||
| 700-030-20 | 10 | Withdrawn | |
| 700-002-34 | Withdrawn | ||
| 700-041-03 | Withdrawn | ||
| 700-058-00 | Withdrawn | ||
| 700-023-13 | Withdrawn | ||
| 700-020-00 | 10 | Withdrawn | |
| 700-035-00 | 10 | Withdrawn | |
| 700-009-00 | Withdrawn | ||
| 700-042-04 | Withdrawn | ||
| 700-027-01 | 10 | Withdrawn | |
| 700-023-44 | Withdrawn | ||
| 700-055-00 | Withdrawn | ||
| 700-002-44 | Withdrawn | ||
| 700-020-03 | Withdrawn | ||
| 700-043-31 | 10 | Withdrawn | |
| 700-041-00 | 10 | Withdrawn | |
| 700-023-33 | Withdrawn | ||
| 700-005-20 | 10 | Withdrawn | |
| 700-040-03 | Withdrawn | ||
| 700-002-03 | Withdrawn | ||
| 700-023-10 | 10 | Withdrawn | |
| 700-002-23 | Withdrawn | ||
| 700-002-40 | 10 | Withdrawn | |
| 700-049-10 | 10 | Withdrawn | |
| 700-049-23 | Withdrawn | ||
| 700-065-00 | 10 | Withdrawn | |
| 700-004-03 | Withdrawn | ||
| 700-002-24 | Withdrawn | ||
| 700-016-00 | 10 | Withdrawn | |
| 700-068-00 | Withdrawn | ||
| 700-037-01 | 10 | Withdrawn | |
| 700-043-41 | 10 | Withdrawn | |
| 700-028-00 | 10 | Withdrawn | |
| 700-005-24 | Withdrawn | ||
| 700-029-10 | 10 | Withdrawn | |
| 700-030-13 | Withdrawn | ||
| 700-030-10 | 10 | Withdrawn | |
| 700-005-03 | Withdrawn | ||
| 700-048-01 | 10 | Withdrawn | |
| 700-003-00 | 10 | Withdrawn | |
| 700-018-00 | 10 | Withdrawn | |
| 700-059-01 | Withdrawn | ||
| 700-029-13 | Withdrawn | ||
| 700-005-13 | Withdrawn | ||
| 700-029-14 | Withdrawn | ||
| 700-049-24 | Withdrawn | ||
| 700-015-04 | Withdrawn | ||
| 700-002-00 | 10 | Withdrawn | |
| 700-019-00 | 10 | Withdrawn | |
| 700-023-40 | 10 | Withdrawn | |
| 700-043-23 | Withdrawn | ||
| 700-016-04 | Withdrawn | ||
| 700-028-01 | 10 | Withdrawn | |
| 700-030-11 | 10 | Withdrawn | |
| 700-023-41 | 10 | Withdrawn | |
| 700-025-03 | Withdrawn | ||
| 700-026-03 | Withdrawn | ||
| 700-040-00 | 10 | Withdrawn | |
| 700-043-10 | 10 | Withdrawn | |
| 700-042-00 | 10 | Withdrawn | |
| 700-029-21 | 10 | Withdrawn | |
| 700-059-00 | Withdrawn | ||
| 700-036-03 | Withdrawn | ||
| 700-058-01 | Withdrawn | ||
| 700-005-44 | Withdrawn | ||
| 700-043-40 | 10 | Withdrawn | |
| 700-050-21 | 10 | Withdrawn | |
| 700-027-00 | 10 | Withdrawn | |
| 700-067-00 | Withdrawn | ||
| 700-029-23 | Withdrawn | ||
| 700-037-04 | Withdrawn | ||
| 700-045-00 | 10 | Withdrawn | |
| 700-049-13 | Withdrawn | ||
| 700-036-00 | 10 | Withdrawn | |
| 700-049-21 | 10 | Withdrawn | |
| 700-064-01 | Withdrawn | ||
| 700-022-03 | Withdrawn | ||
| 700-002-21 | 10 | Withdrawn | |
| 700-002-30 | 10 | Withdrawn | |
| 700-027-03 | Withdrawn | ||
| 700-005-41 | 10 | Withdrawn | |
| 700-043-44 | Withdrawn | ||
| 700-005-11 | 10 | Withdrawn | |
| 700-061-00 | Withdrawn | ||
| 700-030-23 | Withdrawn | ||
| 700-023-20 | 10 | Withdrawn | |
| 700-042-01 | 10 | Withdrawn | |
| 700-006-03 | Withdrawn | ||
| 700-062-01 | Withdrawn | ||
| 700-069-00 | Withdrawn | ||
| 700-050-13 | Withdrawn | ||
| 700-042-03 | Withdrawn | ||
| 700-017-01 | 10 | Withdrawn | |
| 700-016-01 | 10 | Withdrawn | |
| 700-018-01 | 10 | Withdrawn | |
| 700-038-03 | Withdrawn | ||
| 700-039-00 | 10 | Withdrawn | |
| 700-018-03 | Withdrawn | ||
| 700-060-01 | Withdrawn | ||
| 700-005-30 | 10 | Withdrawn | |
| 700-003-03 | Withdrawn | ||
| 700-005-31 | 10 | Withdrawn | |
| 700-007-00 | Withdrawn | ||
| 700-005-21 | 10 | Withdrawn | |
| 700-025-00 | 10 | Withdrawn | |
| 700-030-21 | 10 | Withdrawn | |
| 700-056-00 | Withdrawn | ||
| 700-005-34 | Withdrawn | ||
| 700-028-04 | Withdrawn | ||
| 700-021-04 | Withdrawn | ||
| 700-049-20 | 10 | Withdrawn | |
| 700-035-03 | Withdrawn | ||
| 700-002-10 | 10 | Withdrawn | |
| 700-023-43 | Withdrawn | ||
| 700-048-03 | Withdrawn | ||
| 700-030-14 | Withdrawn | ||
| 700-023-30 | 10 | Withdrawn | |
| 700-023-11 | 10 | Withdrawn | |
| 700-005-23 | Withdrawn | ||
| 700-023-14 | Withdrawn | ||
| 700-029-24 | Withdrawn | ||
| 700-043-34 | Withdrawn | ||
| 700-047-04 | Withdrawn | ||
| 700-001-00 | 10 | Withdrawn | |
| 700-013-00 | Withdrawn | ||
| 700-017-00 | 10 | Withdrawn | |
| 700-023-31 | 10 | Withdrawn | |
| 700-043-43 | Withdrawn | ||
| 700-043-13 | Withdrawn | ||
| 700-017-04 | Withdrawn | ||
| 700-011-00 | Withdrawn | ||
| 700-050-14 | Withdrawn | ||
| 700-049-14 | Withdrawn | ||
| 700-064-00 | Withdrawn | ||
| 700-027-04 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 2,306 |
| BioQuick® | Forestadent Bernhard Förster GmbH | 1,842 |
| Mini Master Series | American Orthodontics | 1,505 |
| Mini-Mono® | Forestadent Bernhard Förster GmbH | 1,225 |
| LP Low Profile | American Orthodontics | 1,204 |
| Mini Sprint® | Forestadent Bernhard Förster GmbH | 1,193 |
| Empower Bracket | American Orthodontics | 1,175 |
| Legend | GC Orthodontics America Inc. | 1,098 |
| Master Series | American Orthodontics | 1,084 |
| Experience® | GC Orthodontics America Inc. | 770 |
| The Orthodontic Store | Young Innovations Inc. | 658 |
| equilibrium® | Dentaurum GmbH & Co. KG | 646 |
Showing 12 of 876. All products under Bracket, Metal, Orthodontic
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.