Dental Operating Light
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (8), Zhejiang (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
Showing 12 of 16. All 16 manufacturers in China registered for Light, Operating, Dental
Record
| Listed by | Safari Dentaire Inc |
|---|---|
| FDA product code | EAZ |
| Device type | Light, Operating, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Premarket notification | Exempt |
| Record published | 2023-10-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAF-302-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 152 |
| Forest | Ls Enterprises, Inc. | 93 |
| DCI Edge | DCI International, LLC | 57 |
| Dentalez | Dentalez Alabama, Inc. | 25 |
| A-dec | A-dec, Inc. | 23 |
| Faro | F.a.r.o. Fabbrica Apparecchiature Razionali Odontoiatriche SPA | 21 |
| Bel-Nova LED | Takara Belmont Corporation | 11 |
| Bel-Halo LED | Takara Belmont Corporation | 10 |
| Bel-Halo Dental Light | Takara Belmont Corporation | 10 |
| Isolite, i2 | Zyris, Inc. | 10 |
| Dental Operating Light | Medfruition Electronics Technology Co., Ltd. | 10 |
| JMU | JMU Dental, Inc | 9 |
Showing 12 of 42. All products under Light, Operating, Dental
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.