Omniarch®
OmniArch® VS BI-DIMENSIONAL® 018/LR3 0T 5A HK
52manufacturers in China registered for this device type
481catalogue 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 | Dentsply Sirona Orthodontics Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-30 |
| Record revised | 2021-02-19 (version 3) |
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, manufacturing date |
| Distribution end date | 2021-02-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 77-451-40 | 10 | Withdrawn | |
| 77-221-01 | 10 | Withdrawn | |
| 77-122-10 | 10 | Withdrawn | |
| 77-212-01 | 10 | Withdrawn | |
| 76-332-10 | 10 | Withdrawn | |
| J77-351-10 | 10 | Withdrawn | |
| 77-331-13 | 10 | Withdrawn | |
| 77-231-91 | 10 | Withdrawn | |
| 77-211-01 | 10 | Withdrawn | |
| 77-241-17 | 10 | Withdrawn | |
| 77-431-71 | 10 | Withdrawn | |
| 77-232-13 | 10 | Withdrawn | |
| 77-121-03 | 10 | Withdrawn | |
| 77-332-12 | 10 | Withdrawn | |
| J77-452-10 | 10 | Withdrawn | |
| 77-651-07 | 10 | Withdrawn | |
| 77-342-91 | 10 | Withdrawn | |
| 77-121-02 | 10 | Withdrawn | |
| 77-341-13 | 10 | Withdrawn | |
| 77-131-13 | 10 | Withdrawn | |
| 77-641-00 | 10 | Withdrawn | |
| J77-341-10 | 10 | Withdrawn | |
| 77-222-10 | 10 | Withdrawn | |
| 77-212-03 | 10 | Withdrawn | |
| 77-342-17 | 10 | Withdrawn | |
| 77-152-17 | 10 | Withdrawn | |
| 77-331-14 | 10 | Withdrawn | |
| 77-132-91 | 10 | Withdrawn | |
| J77-112-00 | 10 | Withdrawn | |
| J77-242-10 | 10 | Withdrawn | |
| 77-122-60 | 10 | Withdrawn | |
| 76-452-10 | 10 | Withdrawn | |
| 77-151-10 | 10 | Withdrawn | |
| J77-222-60 | 10 | Withdrawn | |
| 77-131-22 | 10 | Withdrawn | |
| 77-132-03 | 10 | Withdrawn | |
| 77-332-61 | 10 | Withdrawn | |
| 77-612-00 | 10 | Withdrawn | |
| 76-652-00 | 10 | Withdrawn | |
| 77-432-10 | 10 | Withdrawn | |
| 77-252-17 | 10 | Withdrawn | |
| 77-442-14 | 10 | Withdrawn | |
| J77-651-00 | 10 | Withdrawn | |
| 77-331-10 | 10 | Withdrawn | |
| 77-232-00 | 10 | Withdrawn | |
| 77-122-70 | 10 | Withdrawn | |
| 77-132-11 | 10 | Withdrawn | |
| 77-222-02 | 10 | Withdrawn | |
| J77-231-10 | 10 | Withdrawn | |
| 77-611-40 | 10 | Withdrawn | |
| J77-212-00 | 10 | Withdrawn | |
| 77-441-17 | 10 | Withdrawn | |
| J77-252-61 | 10 | Withdrawn | |
| 77-111-72 | 10 | Withdrawn | |
| 77-141-71 | 10 | Withdrawn | |
| 77-331-61 | 10 | Withdrawn | |
| 77-142-10 | 10 | Withdrawn | |
| 77-341-71 | 10 | Withdrawn | |
| 77-442-90 | 10 | Withdrawn | |
| 77-441-91 | 10 | Withdrawn | |
| 77-651-72 | 10 | Withdrawn | |
| 77-132-14 | 10 | Withdrawn | |
| 77-431-40 | 10 | Withdrawn | |
| 77-341-90 | 10 | Withdrawn | |
| 76-232-10 | 10 | Withdrawn | |
| 76-542-03 | 10 | Withdrawn | |
| 77-132-22 | 10 | Withdrawn | |
| J77-551-00 | 10 | Withdrawn | |
| 77-541-70 | 10 | Withdrawn | |
| 77-221-10 | 10 | Withdrawn | |
| J77-332-10 | 10 | Withdrawn | |
| J77-132-61 | 10 | Withdrawn | |
| 77-211-02 | 10 | Withdrawn | |
| 77-241-90 | 10 | Withdrawn | |
| 77-332-22 | 10 | Withdrawn | |
| 77-342-60 | 10 | Withdrawn | |
| 77-231-12 | 10 | Withdrawn | |
| K77-055-28 | 20 | Withdrawn | |
| 77-111-02 | 10 | Withdrawn | |
| 77-452-10 | 10 | Withdrawn | |
| 77-231-11 | 10 | Withdrawn | |
| 77-131-91 | 10 | Withdrawn | |
| 77-152-10 | 10 | Withdrawn | |
| 77-111-01 | 10 | Withdrawn | |
| 77-431-00 | 10 | Withdrawn | |
| 77-152-61 | 10 | Withdrawn | |
| 77-332-60 | 10 | Withdrawn | |
| 77-431-91 | 10 | Withdrawn | |
| 77-231-10 | 10 | Withdrawn | |
| 77-351-10 | 10 | Withdrawn | |
| 77-231-03 | 10 | Withdrawn | |
| 76-152-10 | 10 | Withdrawn | |
| 77-351-40 | 10 | Withdrawn | |
| 76-432-00 | 10 | Withdrawn | |
| 76-541-72 | 10 | Withdrawn | |
| 77-551-60 | 10 | Withdrawn | |
| 77-251-61 | 10 | Withdrawn | |
| 77-332-13 | 10 | Withdrawn | |
| 77-231-60 | 10 | Withdrawn | |
| 77-332-10 | 10 | Withdrawn | |
| 77-142-17 | 10 | Withdrawn | |
| J77-151-10 | 10 | Withdrawn | |
| J77-232-10 | 10 | Withdrawn | |
| 77-332-03 | 10 | Withdrawn | |
| 77-552-00 | 10 | Withdrawn | |
| 77-432-03 | 10 | Withdrawn | |
| 77-542-04 | 10 | Withdrawn | |
| 76-241-10 | 10 | Withdrawn | |
| 77-221-03 | 10 | Withdrawn | |
| 77-121-70 | 10 | Withdrawn | |
| 77-431-61 | 10 | Withdrawn | |
| 77-342-10 | 10 | Withdrawn | |
| 77-641-33 | 10 | Withdrawn | |
| 76-331-00 | 10 | Withdrawn | |
| 77-222-00 | 10 | Withdrawn | |
| 77-221-40 | 10 | Withdrawn | |
| 77-612-03 | 10 | Withdrawn | |
| 77-331-91 | 10 | Withdrawn | |
| 77-112-60 | 10 | Withdrawn | |
| J77-252-10 | 10 | Withdrawn | |
| 77-122-03 | 10 | Withdrawn | |
| 77-331-00 | 10 | Withdrawn | |
| 77-452-61 | 10 | Withdrawn | |
| 77-231-61 | 10 | Withdrawn | |
| 77-111-90 | 10 | Withdrawn | |
| J77-241-10 | 10 | Withdrawn | |
| 76-641-72 | 10 | Withdrawn | |
| 77-241-10 | 10 | Withdrawn | |
| 77-242-10 | 10 | Withdrawn | |
| 77-112-70 | 10 | Withdrawn | |
| J77-642-00 | 10 | Withdrawn | |
| 77-551-00 | 10 | Withdrawn | |
| K77-055-30 | 20 | Withdrawn | |
| 77-251-17 | 10 | Withdrawn | |
| 77-542-07 | 10 | Withdrawn | |
| 76-651-00 | 10 | Withdrawn | |
| 77-231-22 | 10 | Withdrawn | |
| J77-211-00 | 10 | Withdrawn | |
| 77-121-00 | 10 | Withdrawn | |
| 77-232-22 | 10 | Withdrawn | |
| 77-542-60 | 10 | Withdrawn | |
| J77-442-10 | 10 | Withdrawn | |
| 77-242-13 | 10 | Withdrawn | |
| 76-651-72 | 10 | Withdrawn | |
| 77-351-17 | 10 | Withdrawn | |
| 77-231-71 | 10 | Withdrawn | |
| K77-055-61 | 20 | Withdrawn | |
| 77-452-13 | 10 | Withdrawn | |
| J77-142-61 | 10 | Withdrawn | |
| 77-352-13 | 10 | Withdrawn | |
| 77-131-71 | 10 | Withdrawn | |
| 77-231-90 | 10 | Withdrawn | |
| 77-431-10 | 10 | Withdrawn | |
| 77-331-40 | 10 | Withdrawn | |
| 77-131-11 | 10 | Withdrawn | |
| 77-611-06 | 10 | Withdrawn | |
| J77-131-10 | 10 | Withdrawn | |
| 77-441-71 | 10 | Withdrawn | |
| 76-541-00 | 10 | Withdrawn | |
| 77-331-41 | 10 | Withdrawn | |
| 77-221-60 | 10 | Withdrawn | |
| 77-241-40 | 10 | Withdrawn | |
| 77-141-91 | 10 | Withdrawn | |
| 77-241-61 | 10 | Withdrawn | |
| 77-331-03 | 10 | Withdrawn | |
| 77-232-04 | 10 | Withdrawn | |
| 77-211-03 | 10 | Withdrawn | |
| 77-612-60 | 10 | Withdrawn | |
| 76-652-03 | 10 | Withdrawn | |
| J77-552-60 | 10 | Withdrawn | |
| 77-541-07 | 10 | Withdrawn | |
| 77-431-60 | 10 | Withdrawn | |
| 77-122-00 | 10 | Withdrawn | |
| J77-641-00 | 10 | Withdrawn | |
| K77-055-22 | 20 | Withdrawn | |
| 77-131-41 | 10 | Withdrawn | |
| 77-232-60 | 10 | Withdrawn | |
| 76-641-00 | 10 | Withdrawn | |
| 77-112-01 | 10 | Withdrawn | |
| 77-342-90 | 10 | Withdrawn | |
| 77-442-61 | 10 | Withdrawn | |
| 77-121-01 | 10 | Withdrawn | |
| 76-352-10 | 10 | Withdrawn | |
| 77-112-72 | 10 | Withdrawn | |
| 77-211-70 | 10 | Withdrawn | |
| 77-232-61 | 10 | Withdrawn | |
| 77-541-33 | 10 | Withdrawn | |
| 77-432-71 | 10 | Withdrawn | |
| 77-352-17 | 10 | Withdrawn | |
| 77-212-72 | 10 | Withdrawn | |
| 77-232-10 | 10 | Withdrawn | |
| 77-611-03 | 10 | Withdrawn | |
| 77-221-91 | 10 | Withdrawn | |
| 77-132-00 | 10 | Withdrawn | |
| J77-251-10 | 10 | Withdrawn | |
| 77-221-72 | 10 | Withdrawn | |
| 76-431-00 | 10 | Withdrawn | |
| 77-232-73 | 10 | Withdrawn | |
| 77-131-40 | 10 | Withdrawn | |
| J77-111-00 | 10 | Withdrawn | |
| 77-342-13 | 10 | Withdrawn | |
| 77-432-04 | 10 | Withdrawn | |
| 77-431-12 | 10 | Withdrawn | |
| 77-652-00 | 10 | Withdrawn | |
| 76-442-10 | 10 | Withdrawn | |
| 77-142-90 | 10 | Withdrawn | |
| 77-452-17 | 10 | Withdrawn | |
| 77-442-17 | 10 | Withdrawn | |
| 77-251-10 | 10 | Withdrawn | |
| 77-331-22 | 10 | Withdrawn | |
| 77-112-73 | 10 | Withdrawn | |
| J77-432-61 | 10 | Withdrawn | |
| 77-232-01 | 10 | Withdrawn | |
| 77-341-61 | 10 | Withdrawn | |
| 77-121-10 | 10 | Withdrawn | |
| 77-212-60 | 10 | Withdrawn | |
| 77-132-01 | 10 | Withdrawn | |
| 77-131-03 | 10 | Withdrawn | |
| 77-231-41 | 10 | Withdrawn | |
| 77-121-90 | 10 | Withdrawn | |
| 77-342-61 | 10 | Withdrawn | |
| 77-132-04 | 10 | Withdrawn | |
| J77-221-00 | 10 | Withdrawn | |
| 77-111-00 | 10 | Withdrawn | |
| K77-552-92 | 20 | Withdrawn | |
| 76-211-00 | 10 | Withdrawn | |
| J77-441-10 | 10 | Withdrawn | |
| 77-542-34 | 10 | Withdrawn | |
| 77-131-10 | 10 | Withdrawn | |
| 77-112-00 | 10 | Withdrawn | |
| 77-222-90 | 10 | Withdrawn | |
| J77-611-00 | 10 | Withdrawn | |
| 77-441-60 | 10 | Withdrawn | |
| 77-442-13 | 10 | Withdrawn | |
| 77-642-33 | 10 | Withdrawn | |
| 77-222-01 | 10 | Withdrawn | |
| 77-111-70 | 10 | Withdrawn | |
| 77-131-14 | 10 | Withdrawn | |
| 77-331-90 | 10 | Withdrawn | |
| 77-441-61 | 10 | Withdrawn | |
| 77-112-02 | 10 | Withdrawn | |
| 77-432-73 | 10 | Withdrawn | |
| 77-132-12 | 10 | Withdrawn | |
| 77-431-90 | 10 | Withdrawn | |
| J77-452-60 | 10 | Withdrawn | |
| KJ77-055-12 | 20 | Withdrawn | |
| 77-142-14 | 10 | Withdrawn | |
| 77-232-71 | 10 | Withdrawn | |
| 77-131-00 | 10 | Withdrawn | |
| 77-341-60 | 10 | Withdrawn |
Showing 250 of 300 catalogue numbers.
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.