Mavrik Dental System
TheraSmile Console
56manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (28), Jiangsu (6), Shanghai (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| HI-P (Xiamen) Precision Plastic Manufacturing Co., | Xiamen | Fujian | Contract manufacturer | 6 |
| Guangdong Roman Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Yamada Electric Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Taizhou Polus Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 56. All 56 manufacturers in China registered for Heat Source For Bleaching Teeth
Record
| Listed by | Mavrik Dental System Inc. |
|---|---|
| FDA product code | EEG |
| Device type | Heat Source For Bleaching Teeth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6475 |
| Premarket notification | Exempt |
| Record published | 2023-11-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Box of 8, box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | In distribution | |
| 01 | In distribution | |
| 1 | In distribution | |
| 13 | In distribution | |
| 1 | In distribution | |
| 8 | In distribution | |
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ahvte | Foshan Ousidun Personal Care Products Co., Ltd. | 14 |
| Cavex | Hexa Dental | 3 |
| Pioon | Wuhan Pioon Technology Co., Ltd. | 2 |
| Colgate Optic White Professional In Office Whitening Kit | Colgate Oral Pharmaceuticals, Inc. | 2 |
| Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | 2 |
| Hexa | Hexa Dental | 2 |
| Cavex Bite&White Ready 2 Use | Cavex Holland B.V. | 2 |
| Cavex Bite&White ExSense tube | Cavex Holland B.V. | 2 |
| Apoza | Apoza Enterprise Co., Ltd. | 2 |
| Cavex Bite&White patient kit | Cavex Holland B.V. | 1 |
| PhytoLight | PhotoDynamic Incorporated | 1 |
| GuruNanda Professional Whitening Wireless Kit | Gurunanda LLC | 1 |
Showing 12 of 48. All products under Heat Source For Bleaching Teeth
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.