Henry Schein
Maxitab Tartar & Stain
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | JER |
| Device type | Cleaner, Denture, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3530 |
| Premarket notification | Exempt |
| Record published | 2019-05-15 |
| Record revised | 2020-07-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9004089 | 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 |
| Effdnt Dent Bath KIT 1CT | Medtech Products, Inc. | 1 |
| Cleanlets | Sultan Healthcare Inc | 1 |
| Sympro | Renfert Gmbh | 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.