Pioon
The medical diode laser(UTU3-G7W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a…
The medical diode laser(UTU3-G7W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.The device utilizes a solid state diode as laser energy source.The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.The UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively.
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 | Wuhan Pioon Technology Co., Ltd., China |
|---|---|
| FDA product code | EEG |
| Device type | Heat Source For Bleaching Teeth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6475 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2025-07-08 |
| Record revised | 2026-03-27 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2025-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UTU3-G7W | Withdrawn | |
| UTU3-G7B | Withdrawn |
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 |
| 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.