Osstem Implant Co., Ltd.
The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a…
The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual. The BeauTis White Light is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light. The degree of protection against harmful ingress of water is IP21
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 | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | EEG |
| Device type | Heat Source For Bleaching Teeth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6475 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BeauTis Light S | In distribution | |
| BeauTis White Light | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ahvte | Foshan Ousidun Personal Care Products Co., Ltd. | 14 |
| Mavrik Dental System | Mavrik Dental System Inc. | 7 |
| Cavex | Hexa Dental | 3 |
| Pioon | Wuhan Pioon Technology Co., Ltd. | 2 |
| Colgate Optic White Professional In Office Whitening Kit | Colgate Oral Pharmaceuticals, Inc. | 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.