Effdnt Dent Bath KIT 1CT
Eferdent Dent Bath KIT 1CT
12manufacturers in China registered for this device type
1catalogue number
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 | Medtech Products, Inc., United States |
|---|---|
| FDA product code | JER |
| Device type | Cleaner, Denture, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3530 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
| Record revised | 2025-06-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10814832011090 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Britedent | Bright Supply Inc | 6 |
| Pro Clean | Premier Dental Products Co. | 3 |
| Cordless Sonic Cleaner | Dentsply Sirona Orthodontics Inc. | 2 |
| 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.