Cordless Sonic Cleaner
Personalized Cordless Sonic Cleaner
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Hebei (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Shenzhen Yiguangnian Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 13 |
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
| AOJ Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Dongguan Mingchuangyoushang Electronic Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 8 |
Record
| Listed by | Dentsply Sirona Orthodontics Inc., United States |
|---|---|
| FDA product code | JER |
| Device type | Cleaner, Denture, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-13 |
| Record revised | 2024-01-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RB-USC-C | In distribution | |
| RB-USC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Britedent | Bright Supply Inc | 6 |
| Pro Clean | Premier Dental Products Co. | 3 |
| Effdnt Dent Bath KIT 1CT | Medtech Products, Inc. | 1 |
| Cleanlets | Sultan Healthcare Inc | 1 |
| Sympro | Renfert Gmbh | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| AOJ | Shenzhen AOJ Health Science & Technology Co., Ltd. | 1 |
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.