Pinnacle
Pinnacle 022 MC(0T) U/L 5x5 Hks 345 SPK, OS Pad U/L 4/5 SPK
52manufacturers in China registered for this device type
143catalogue 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 | Ortho Technology, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2018-09-19 |
| Record revised | 2025-01-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-09-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 360-92-2031 | In distribution | |
| 360-91-2031 | In distribution | |
| 360-91-2301 | In distribution | |
| 360-91-2010 | In distribution | |
| 360-22-2900 | In distribution | |
| 360-92-3301 | In distribution | |
| 360-91-1100 | In distribution | |
| 360-22-4400 | In distribution | |
| 360-92-3522 | In distribution | |
| 360-92-4432 | In distribution | |
| 360-91-2030 | In distribution | |
| 360-22-4430 | In distribution | |
| 360-92-3422 | In distribution | |
| 360-92-4512 | In distribution | |
| 360-92-2912 | In distribution | |
| 360-91-4422 | In distribution | |
| 360-92-3432 | In distribution | |
| 360-91-2200 | In distribution | |
| 360-22-3410 | In distribution | |
| 360-91-1922 | In distribution | |
| 360-22-3340 | In distribution | |
| 360-91-4532 | In distribution | |
| 360-91-4522 | In distribution | |
| 360-91-4502 | In distribution | |
| 360-91-3522 | In distribution | |
| 360-92-2200 | In distribution | |
| 360-22-4500 | In distribution | |
| 360-91-3412 | In distribution | |
| 360-92-1301 | In distribution | |
| 360-91-3301 | In distribution | |
| 360-92-4402 | In distribution | |
| 360-22-1340 | In distribution | |
| 360-92-1902 | In distribution | |
| 360-22-2920 | In distribution | |
| 360-22-3400 | In distribution | |
| 360-92-1200 | In distribution | |
| 360-92-2000 | In distribution | |
| 360-92-1912 | In distribution | |
| 360-91-3512 | In distribution | |
| 360-22-2051 | In distribution | |
| 360-92-4502 | In distribution | |
| 360-22-4350 | In distribution | |
| 360-92-1922 | In distribution | |
| 360-22-2300 | In distribution | |
| 360-22-2310 | In distribution | |
| 360-92-2020 | In distribution | |
| 360-91-3402 | In distribution | |
| 360-22-2010 | In distribution | |
| 360-92-2030 | In distribution | |
| 360-22-3510 | In distribution | |
| 360-91-6800 | In distribution | |
| 360-92-2311 | In distribution | |
| 360-91-1200 | In distribution | |
| 360-22-3530 | In distribution | |
| 360-91-3532 | In distribution | |
| 360-92-4532 | In distribution | |
| 360-92-3532 | In distribution | |
| 360-22-1920 | In distribution | |
| 360-22-2011 | In distribution | |
| 360-92-4522 | In distribution | |
| 360-22-4420 | In distribution | |
| 360-92-2932 | In distribution | |
| 360-92-2922 | In distribution | |
| 360-91-4432 | In distribution | |
| 360-22-3350 | In distribution | |
| 360-22-1350 | In distribution | |
| 360-92-4311 | In distribution | |
| 360-91-4311 | In distribution | |
| 360-22-1200 | In distribution | |
| 360-22-2910 | In distribution | |
| 360-22-2050 | In distribution | |
| 360-22-3420 | In distribution | |
| 360-91-2100 | In distribution | |
| 360-22-2062 | In distribution | |
| 360-22-4310 | In distribution | |
| 360-92-4412 | In distribution | |
| 360-91-2011 | In distribution | |
| 360-92-2902 | In distribution | |
| 360-92-1311 | In distribution | |
| 360-22-3500 | In distribution | |
| 360-92-4422 | In distribution | |
| 360-91-3432 | In distribution | |
| 360-91-2902 | In distribution | |
| 360-22-2031 | In distribution | |
| 360-91-4301 | In distribution | |
| 360-22-4300 | In distribution | |
| 360-92-1100 | In distribution | |
| 360-22-1900 | In distribution | |
| 360-91-4412 | In distribution | |
| 360-92-4301 | In distribution | |
| 360-22-2030 | In distribution | |
| 360-92-3512 | In distribution | |
| 360-22-1100 | In distribution | |
| 360-22-1930 | In distribution | |
| 360-91-4402 | In distribution | |
| 360-91-3422 | In distribution | |
| 360-22-1910 | In distribution | |
| 360-91-1912 | In distribution | |
| 360-91-4512 | In distribution | |
| 360-22-2061 | In distribution | |
| 360-22-4410 | In distribution | |
| 360-22-2200 | In distribution | |
| 360-92-2010 | In distribution | |
| 360-22-3520 | In distribution | |
| 360-91-1932 | In distribution | |
| 360-91-2922 | In distribution | |
| 360-92-6800 | In distribution | |
| 360-22-2340 | In distribution | |
| 360-22-1300 | In distribution | |
| 360-91-1311 | In distribution | |
| 360-91-2912 | In distribution | |
| 360-22-6800 | In distribution | |
| 360-22-2100 | In distribution | |
| 360-91-2932 | In distribution | |
| 360-22-4520 | In distribution | |
| 360-92-2100 | In distribution | |
| 360-22-3300 | In distribution | |
| 360-91-1301 | In distribution | |
| 360-92-1932 | In distribution | |
| 360-91-3502 | In distribution | |
| 360-22-1310 | In distribution | |
| 360-22-2350 | In distribution | |
| 360-22-4530 | In distribution | |
| 360-22-3310 | In distribution | |
| 360-92-3311 | In distribution | |
| 360-22-4510 | In distribution | |
| 360-92-2011 | In distribution | |
| 360-91-3311 | In distribution | |
| 360-22-2930 | In distribution | |
| 360-91-2311 | In distribution | |
| 360-92-3412 | In distribution | |
| 360-92-3402 | In distribution | |
| 360-92-3502 | In distribution | |
| 360-91-1902 | In distribution | |
| 360-92-2301 | In distribution | |
| 360-22-3430 | In distribution | |
| 360-22-4340 | In distribution | |
| 360-22-2020 | Withdrawn | |
| 360-22-2000 | Withdrawn | |
| 360-91-2000 | Withdrawn | |
| 360-91-2020 | Withdrawn | |
| 360-22-2060 | Withdrawn | |
| 360-22-2040 | 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.