OptiTwist®
Vacuum Mixing Bowl
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Hebei (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
Showing 12 of 14. All 14 manufacturers in China registered for Mixer, Cement, For Clinical Use
Record
| Listed by | Summit Medical LLC, United States |
|---|---|
| FDA product code | JDZ |
| Device type | Mixer, Cement, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600-40-020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 26 |
| DJO Surgical | Encore Medical, L.P. | 23 |
| Mixer, Cement, For Clinical Use | Stryker GmbH | 22 |
| Revolution | Stryker GmbH | 17 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 15 |
| Midway Select | Midway Dental Supply, LLC | 8 |
| Mixor | Smith & Nephew, Inc. | 7 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 6 |
| Mini-Bowls | Pulpdent Corporation | 4 |
| AutoPlex, VertaPlex | Stryker GmbH | 4 |
| Quick-Vac® Vacuum Mixing Bowl | Summit Medical LLC | 4 |
| Henry Schein | Henry Schein, Inc. | 3 |
Showing 12 of 84. All products under Mixer, Cement, For Clinical Use
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.