Orthometric Advanced Series Bracket
Metal Bracket Advanced Series Roth 0,022-KIT W/ 1 Set+wire+modular Elastic
52manufacturers in China registered for this device type
111catalogue 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 | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2022-09-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10.11.2521 | In distribution | |
| 10.13.2531 | In distribution | |
| 10.13.2523 | In distribution | |
| 10.11.2512 | In distribution | |
| 10.11.2522 | In distribution | |
| 10.14.2523 | In distribution | |
| 10.10.2918 | In distribution | |
| 10.12.2531 | In distribution | |
| 10.10.2935 | In distribution | |
| 10.11.2535 | In distribution | |
| 10.12.2521 | In distribution | |
| 10.10.3001 | In distribution | |
| 10.10.2545 | In distribution | |
| 10.11.2544 | In distribution | |
| 10.11.2543 | In distribution | |
| 10.12.2000 | In distribution | |
| 10.10.2523 | In distribution | |
| 10.10.2521 | In distribution | |
| 10.10.2543 | In distribution | |
| 10.14.2000 | In distribution | |
| 10.12.2311 | In distribution | |
| 10.11.2918 | In distribution | |
| 10.10.2534 | In distribution | |
| 10.11.2531 | In distribution | |
| 10.10.2612 | In distribution | |
| 10.11.2533 | In distribution | |
| 10.11.2915 | In distribution | |
| 10.13.2000 | In distribution | |
| 10.12.2513 | In distribution | |
| 10.11.2541 | In distribution | |
| 10.11.2534 | In distribution | |
| 10.10.2512 | In distribution | |
| 10.10.2513 | In distribution | |
| 10.10.2201 | In distribution | |
| 10.10.2920 | In distribution | |
| 10.12.2543 | In distribution | |
| 10.11.2910 | In distribution | |
| 10.14.2521 | In distribution | |
| 10.10.2927 | In distribution | |
| 10.10.2100 | In distribution | |
| 10.10.2200 | In distribution | |
| 10.10.2223 | In distribution | |
| 10.10.2622 | In distribution | |
| 10.10.2934 | In distribution | |
| 10.14.2533 | In distribution | |
| 10.12.2541 | In distribution | |
| 10.10.2910 | In distribution | |
| 10.10.2213 | In distribution | |
| 10.14.2512 | In distribution | |
| 10.11.2917 | In distribution | |
| 10.11.2950 | In distribution | |
| 10.11.2514 | In distribution | |
| 10.10.2531 | In distribution | |
| 10.10.2950 | In distribution | |
| 10.12.2512 | In distribution | |
| 10.12.2533 | In distribution | |
| 10.10.2922 | In distribution | |
| 10.10.2000 | In distribution | |
| 10.11.2807 | In distribution | |
| 10.14.2513 | In distribution | |
| 10.10.2544 | In distribution | |
| 10.14.2522 | In distribution | |
| 10.13.2513 | In distribution | |
| 10.12.2523 | In distribution | |
| 10.10.2524 | In distribution | |
| 10.11.2511 | In distribution | |
| 10.10.2113 | In distribution | |
| 10.10.2533 | In distribution | |
| 10.10.2921 | In distribution | |
| 10.11.2912 | In distribution | |
| 10.10.2621 | In distribution | |
| 10.10.2911 | In distribution | |
| 10.11.2919 | In distribution | |
| 10.11.2900 | In distribution | |
| 10.10.2203 | In distribution | |
| 10.14.2543 | In distribution | |
| 10.11.2913 | In distribution | |
| 10.10.2923 | In distribution | |
| 10.12.2524 | In distribution | |
| 10.10.2611 | In distribution | |
| 10.10.2112 | In distribution | |
| 10.10.2631 | In distribution | |
| 10.10.2535 | In distribution | |
| 10.10.2101 | In distribution | |
| 10.12.2514 | In distribution | |
| 10.10.2103 | In distribution | |
| 10.12.2535 | In distribution | |
| 10.11.2916 | In distribution | |
| 10.10.2511 | In distribution | |
| 10.14.2511 | In distribution | |
| 10.10.3000 | In distribution | |
| 10.11.2911 | In distribution | |
| 10.10.2514 | In distribution | |
| 10.10.2919 | In distribution | |
| 10.12.2544 | In distribution | |
| 10.10.2522 | In distribution | |
| 10.11.2000 | In distribution | |
| 10.10.2111 | In distribution | |
| 10.10.2102 | In distribution | |
| 10.10.2202 | In distribution | |
| 10.12.2522 | In distribution | |
| 10.11.2523 | In distribution | |
| 10.14.2531 | In distribution | |
| 10.11.2524 | In distribution | |
| 10.12.2545 | In distribution | |
| 10.10.2900 | In distribution | |
| 10.11.2545 | In distribution | |
| 10.11.2513 | In distribution | |
| 10.13.2541 | In distribution | |
| 10.12.2534 | In distribution | |
| 10.10.2924 | In distribution |
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.