IN-Ovation® R
IN-OVATION® R Base Rx SP 022 UL/5-5 CS-BC DHK
52manufacturers in China registered for this device type
341catalogue 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 | 2021-01-20 (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 |
|---|---|---|---|
| 189-352-07 | 10 | Withdrawn | |
| 189-342-61 | 10 | Withdrawn | |
| 189-112-03 | 10 | Withdrawn | |
| 189-131-06 | 10 | Withdrawn | |
| 189-441-00 | 10 | Withdrawn | |
| 189-212-80 | 10 | Withdrawn | |
| 189-352-08 | 10 | Withdrawn | |
| K189-055-23 | 20 | Withdrawn | |
| 189-142-17 | 10 | Withdrawn | |
| 189-221-07 | 10 | Withdrawn | |
| 189-432-82 | 10 | Withdrawn | |
| K189-552-81 | 20 | Withdrawn | |
| 189-211-08 | 10 | Withdrawn | |
| 189-141-13 | 10 | Withdrawn | |
| 189-641-03 | 10 | Withdrawn | |
| 189-141-00 | 10 | Withdrawn | |
| 189-222-00 | 10 | Withdrawn | |
| 189-242-17 | 10 | Withdrawn | |
| 189-351-13 | 10 | Withdrawn | |
| K189-055-26 | 20 | Withdrawn | |
| 189-411-22 | 10 | Withdrawn | |
| 189-210-00 | 10 | Withdrawn | |
| 189-452-10 | 10 | Withdrawn | |
| 189-452-81 | 10 | Withdrawn | |
| 189-341-17 | 10 | Withdrawn | |
| 189-132-41 | 10 | Withdrawn | |
| 189-231-16 | 10 | Withdrawn | |
| 189-111-07 | 10 | Withdrawn | |
| 189-242-41 | 10 | Withdrawn | |
| 189-112-08 | 10 | Withdrawn | |
| 189-431-60 | 10 | Withdrawn | |
| 189-112-02 | 10 | Withdrawn | |
| 189-342-17 | 10 | Withdrawn | |
| 189-351-08 | 10 | Withdrawn | |
| 189-142-90 | 10 | Withdrawn | |
| 189-232-81 | 10 | Withdrawn | |
| K189-003-00 | 26 | Withdrawn | |
| 189-222-02 | 10 | Withdrawn | |
| 189-411-00 | 10 | Withdrawn | |
| K189-551-83U | 10 | Withdrawn | |
| 189-612-08 | 10 | Withdrawn | |
| 189-231-00 | 10 | Withdrawn | |
| 189-452-07 | 10 | Withdrawn | |
| 189-432-17 | 10 | Withdrawn | |
| 189-332-81 | 10 | Withdrawn | |
| 189-242-10 | 10 | Withdrawn | |
| 189-611-03 | 10 | Withdrawn | |
| K189-017-08 | 20 | Withdrawn | |
| 189-442-08 | 10 | Withdrawn | |
| 189-442-17 | 10 | Withdrawn | |
| 189-441-07 | 10 | Withdrawn | |
| 189-220-00 | 10 | Withdrawn | |
| 189-231-61 | 10 | Withdrawn | |
| 189-310-00 | 10 | Withdrawn | |
| 189-432-10 | 10 | Withdrawn | |
| 189-232-10 | 10 | Withdrawn | |
| 189-341-08 | 10 | Withdrawn | |
| 189-120-00 | 10 | Withdrawn | |
| 189-242-60 | 10 | Withdrawn | |
| 189-612-07 | 10 | Withdrawn | |
| 189-432-41 | 10 | Withdrawn | |
| 189-111-03 | 10 | Withdrawn | |
| 189-141-81 | 10 | Withdrawn | |
| 189-331-61 | 10 | Withdrawn | |
| 189-132-06 | 10 | Withdrawn | |
| 189-641-02 | 10 | Withdrawn | |
| 189-441-60 | 10 | Withdrawn | |
| 189-342-60 | 10 | Withdrawn | |
| 189-152-81 | 10 | Withdrawn | |
| 189-111-60 | 10 | Withdrawn | |
| 189-351-00 | 10 | Withdrawn | |
| 189-242-00 | 10 | Withdrawn | |
| 189-331-10 | 10 | Withdrawn | |
| 189-332-82 | 10 | Withdrawn | |
| 189-131-82 | 10 | Withdrawn | |
| 189-232-80 | 10 | Withdrawn | |
| 189-242-61 | 10 | Withdrawn | |
| 189-142-81 | 10 | Withdrawn | |
| 189-431-10 | 10 | Withdrawn | |
| 189-332-10 | 10 | Withdrawn | |
| 189-222-80 | 10 | Withdrawn | |
| K189-552-82 | 20 | Withdrawn | |
| 189-451-80 | 10 | Withdrawn | |
| K189-110-00 | 20 | Withdrawn | |
| 189-451-17 | 10 | Withdrawn | |
| 189-232-82 | 10 | Withdrawn | |
| 189-351-07 | 10 | Withdrawn | |
| 189-611-08 | 10 | Withdrawn | |
| 189-132-00 | 10 | Withdrawn | |
| 189-241-81 | 10 | Withdrawn | |
| 189-121-02 | 10 | Withdrawn | |
| K189-017-07 | 20 | Withdrawn | |
| 189-232-00 | 10 | Withdrawn | |
| 189-232-18 | 10 | Withdrawn | |
| 189-331-60 | 10 | Withdrawn | |
| 189-232-61 | 10 | Withdrawn | |
| 189-311-22 | 10 | Withdrawn | |
| 189-231-17 | 10 | Withdrawn | |
| 189-432-80 | 10 | Withdrawn | |
| 189-442-80 | 10 | Withdrawn | |
| 189-332-80 | 10 | Withdrawn | |
| 189-652-03 | 10 | Withdrawn | |
| 189-121-00 | 10 | Withdrawn | |
| 189-431-81 | 10 | Withdrawn | |
| 189-211-03 | 10 | Withdrawn | |
| 189-612-03 | 10 | Withdrawn | |
| 189-322-10 | 10 | Withdrawn | |
| 189-311-00 | 10 | Withdrawn | |
| 189-232-41 | 10 | Withdrawn | |
| 189-352-81 | 10 | Withdrawn | |
| 189-232-12 | 10 | Withdrawn | |
| 189-132-82 | 10 | Withdrawn | |
| 189-232-17 | 10 | Withdrawn | |
| 189-452-13 | 10 | Withdrawn | |
| 189-131-16 | 10 | Withdrawn | |
| 189-332-60 | 10 | Withdrawn | |
| 189-231-82 | 10 | Withdrawn | |
| 189-231-06 | 10 | Withdrawn | |
| 189-332-17 | 10 | Withdrawn | |
| 189-612-80 | 10 | Withdrawn | |
| 189-121-08 | 10 | Withdrawn | |
| 189-122-60 | 10 | Withdrawn | |
| 189-342-00 | 10 | Withdrawn | |
| 189-121-60 | 10 | Withdrawn | |
| 189-451-00 | 10 | Withdrawn | |
| 189-221-10 | 10 | Withdrawn | |
| K189-055-13 | 20 | Withdrawn | |
| 189-342-10 | 10 | Withdrawn | |
| 189-142-61 | 10 | Withdrawn | |
| 189-652-02 | 10 | Withdrawn | |
| 189-131-13 | 10 | Withdrawn | |
| 189-432-81 | 10 | Withdrawn | |
| 189-441-81 | 10 | Withdrawn | |
| 189-441-80 | 10 | Withdrawn | |
| 189-342-81 | 10 | Withdrawn | |
| 189-211-02 | 10 | Withdrawn | |
| 189-341-13 | 10 | Withdrawn | |
| 189-141-60 | 10 | Withdrawn | |
| 189-221-00 | 10 | Withdrawn | |
| 189-231-13 | 10 | Withdrawn | |
| 189-451-07 | 10 | Withdrawn | |
| 189-542-03 | 10 | Withdrawn | |
| 189-432-60 | 10 | Withdrawn | |
| 189-221-60 | 10 | Withdrawn | |
| 189-442-60 | 10 | Withdrawn | |
| 189-352-13 | 10 | Withdrawn | |
| 189-111-00 | 10 | Withdrawn | |
| 189-132-17 | 10 | Withdrawn | |
| 189-612-02 | 10 | Withdrawn | |
| 189-410-00 | 10 | Withdrawn | |
| 189-351-17 | 10 | Withdrawn | |
| 189-431-13 | 10 | Withdrawn | |
| 189-142-60 | 10 | Withdrawn | |
| 189-412-22 | 10 | Withdrawn | |
| 189-232-60 | 10 | Withdrawn | |
| 189-551-80 | 10 | Withdrawn | |
| 189-431-17 | 10 | Withdrawn | |
| 189-331-81 | 10 | Withdrawn | |
| 189-431-00 | 10 | Withdrawn | |
| 189-611-80 | 10 | Withdrawn | |
| 189-451-13 | 10 | Withdrawn | |
| 189-232-06 | 10 | Withdrawn | |
| 189-141-17 | 10 | Withdrawn | |
| 189-142-00 | 10 | Withdrawn | |
| 189-122-03 | 10 | Withdrawn | |
| K189-055-16 | 20 | Withdrawn | |
| 189-342-13 | 10 | Withdrawn | |
| 189-451-81 | 10 | Withdrawn | |
| 189-341-00 | 10 | Withdrawn | |
| 189-541-80 | 10 | Withdrawn | |
| 189-222-60 | 10 | Withdrawn | |
| K189-551-82 | 20 | Withdrawn | |
| 189-342-41 | 10 | Withdrawn | |
| 189-142-13 | 10 | Withdrawn | |
| 189-232-13 | 10 | Withdrawn | |
| 189-422-10 | 10 | Withdrawn | |
| 189-112-00 | 10 | Withdrawn | |
| 189-222-08 | 10 | Withdrawn | |
| 189-351-10 | 10 | Withdrawn | |
| 189-432-13 | 10 | Withdrawn | |
| 189-541-07 | 10 | Withdrawn | |
| 189-131-10 | 10 | Withdrawn | |
| 189-222-61 | 10 | Withdrawn | |
| 189-312-00 | 10 | Withdrawn | |
| 189-431-82 | 10 | Withdrawn | |
| 189-312-22 | 10 | Withdrawn | |
| 189-112-07 | 10 | Withdrawn | |
| 189-121-03 | 10 | Withdrawn | |
| 189-441-13 | 10 | Withdrawn | |
| 189-442-10 | 10 | Withdrawn | |
| 189-341-61 | 10 | Withdrawn | |
| 189-121-07 | 10 | Withdrawn | |
| K189-018-08 | 20 | Withdrawn | |
| 189-352-10 | 10 | Withdrawn | |
| 189-442-61 | 10 | Withdrawn | |
| 189-442-13 | 10 | Withdrawn | |
| 189-121-10 | 10 | Withdrawn | |
| 189-122-07 | 10 | Withdrawn | |
| 189-341-07 | 10 | Withdrawn | |
| 189-212-07 | 10 | Withdrawn | |
| 189-452-80 | 10 | Withdrawn | |
| 189-352-17 | 10 | Withdrawn | |
| 189-241-00 | 10 | Withdrawn | |
| 189-332-12 | 10 | Withdrawn | |
| 189-231-60 | 10 | Withdrawn | |
| 189-242-13 | 10 | Withdrawn | |
| 189-642-40 | 10 | Withdrawn | |
| 189-352-00 | 10 | Withdrawn | |
| 189-131-00 | 10 | Withdrawn | |
| K189-017-18 | 20 | Withdrawn | |
| K189-055-22 | 20 | Withdrawn | |
| 189-352-80 | 10 | Withdrawn | |
| 189-541-03 | 10 | Withdrawn | |
| 189-122-08 | 10 | Withdrawn | |
| 189-212-08 | 10 | Withdrawn | |
| 189-252-81 | 10 | Withdrawn | |
| 189-441-61 | 10 | Withdrawn | |
| 189-141-90 | 10 | Withdrawn | |
| 189-231-81 | 10 | Withdrawn | |
| 189-212-03 | 10 | Withdrawn | |
| 189-651-03 | 10 | Withdrawn | |
| 189-211-60 | 10 | Withdrawn | |
| 189-242-90 | 10 | Withdrawn | |
| 189-331-13 | 10 | Withdrawn | |
| 189-221-61 | 10 | Withdrawn | |
| 189-611-60 | 10 | Withdrawn | |
| 189-431-12 | 10 | Withdrawn | |
| 189-611-07 | 10 | Withdrawn | |
| 189-232-16 | 10 | Withdrawn | |
| 189-212-60 | 10 | Withdrawn | |
| 189-131-18 | 10 | Withdrawn | |
| 189-211-80 | 10 | Withdrawn | |
| K189-055-93 | 20 | Withdrawn | |
| 189-132-13 | 10 | Withdrawn | |
| 189-552-80 | 10 | Withdrawn | |
| 189-542-02 | 10 | Withdrawn | |
| 189-611-02 | 10 | Withdrawn | |
| 189-122-00 | 10 | Withdrawn | |
| 189-342-08 | 10 | Withdrawn | |
| 189-141-61 | 10 | Withdrawn | |
| 189-141-10 | 10 | Withdrawn | |
| 189-231-10 | 10 | Withdrawn | |
| 189-441-08 | 10 | Withdrawn | |
| 189-241-17 | 10 | Withdrawn | |
| 189-121-61 | 10 | Withdrawn | |
| 189-241-10 | 10 | Withdrawn | |
| 189-132-10 | 10 | Withdrawn | |
| K189-018-07 | 20 | Withdrawn | |
| 189-331-12 | 10 | Withdrawn | |
| 189-131-12 | 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.