Mini Ovation®
MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
52manufacturers in China registered for this device type
66catalogue 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 | 2021-09-23 (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 |
|---|---|---|---|
| 85-451-00 | 10 | Withdrawn | |
| 85-412-02 | 10 | Withdrawn | |
| 85-232-16 | 10 | Withdrawn | |
| 85-242-90 | 10 | Withdrawn | |
| K85-055-24 | 20 | Withdrawn | |
| 85-241-00 | 10 | Withdrawn | |
| 85-122-00 | 10 | Withdrawn | |
| 85-332-10 | 10 | Withdrawn | |
| 85-351-00 | 10 | Withdrawn | |
| 85-132-16 | 10 | Withdrawn | |
| 85-341-10 | 10 | Withdrawn | |
| 85-331-10 | 10 | Withdrawn | |
| 85-352-14 | 10 | Withdrawn | |
| 85-231-16 | 10 | Withdrawn | |
| 85-141-00 | 10 | Withdrawn | |
| 85-342-00 | 10 | Withdrawn | |
| 85-132-10 | 10 | Withdrawn | |
| 85-411-00 | 10 | Withdrawn | |
| 85-131-10 | 10 | Withdrawn | |
| 85-451-10 | 10 | Withdrawn | |
| 85-452-10 | 10 | Withdrawn | |
| 85-352-00 | 10 | Withdrawn | |
| 85-351-14 | 10 | Withdrawn | |
| 85-131-16 | 10 | Withdrawn | |
| 85-142-90 | 10 | Withdrawn | |
| 85-432-10 | 10 | Withdrawn | |
| 85-452-14 | 10 | Withdrawn | |
| 85-222-00 | 10 | Withdrawn | |
| 85-311-00 | 10 | Withdrawn | |
| 85-442-14 | 10 | Withdrawn | |
| 85-221-00 | 10 | Withdrawn | |
| 85-232-00 | 10 | Withdrawn | |
| 85-132-00 | 10 | Withdrawn | |
| 85-242-00 | 10 | Withdrawn | |
| 85-341-14 | 10 | Withdrawn | |
| 85-441-14 | 10 | Withdrawn | |
| 85-241-90 | 10 | Withdrawn | |
| 85-451-14 | 10 | Withdrawn | |
| 85-431-00 | 10 | Withdrawn | |
| 85-431-10 | 10 | Withdrawn | |
| 85-212-00 | 10 | Withdrawn | |
| 85-332-00 | 10 | Withdrawn | |
| 85-412-00 | 10 | Withdrawn | |
| 85-342-10 | 10 | Withdrawn | |
| 85-211-00 | 10 | Withdrawn | |
| 85-142-00 | 10 | Withdrawn | |
| 85-112-00 | 10 | Withdrawn | |
| 85-121-00 | 10 | Withdrawn | |
| K85-055-23 | 20 | Withdrawn | |
| 85-111-00 | 10 | Withdrawn | |
| 85-441-00 | 10 | Withdrawn | |
| 85-232-10 | 10 | Withdrawn | |
| 85-342-14 | 10 | Withdrawn | |
| 85-452-00 | 10 | Withdrawn | |
| 85-141-90 | 10 | Withdrawn | |
| 85-432-00 | 10 | Withdrawn | |
| 85-442-10 | 10 | Withdrawn | |
| 85-312-00 | 10 | Withdrawn | |
| 85-341-00 | 10 | Withdrawn | |
| 85-312-02 | 10 | Withdrawn | |
| 85-231-10 | 10 | Withdrawn | |
| 85-441-10 | 10 | Withdrawn | |
| 85-411-02 | 10 | Withdrawn | |
| 85-351-10 | 10 | Withdrawn | |
| 85-352-10 | 10 | Withdrawn | |
| 85-442-00 | 10 | 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.