DCI Edge
Light Head Adapter Conversion Kit, Pelton & Crane, 120 Volt
16manufacturers in China registered for this device type
57catalogue numbers in this listing
2recalls on this code
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 | DCI International, LLC, United States |
|---|---|
| FDA product code | EAZ |
| Device type | Light, Operating, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RP | In distribution | |
| LC5 | In distribution | |
| LC4 | In distribution | |
| RP | In distribution | |
| LP5 | In distribution | |
| LP5 | In distribution | |
| LC4 | In distribution | |
| LC5 | In distribution | |
| LP4 | In distribution | |
| LT4 | In distribution | |
| LX4 | In distribution | |
| RP | In distribution | |
| LC5 | In distribution | |
| LC4 | In distribution | |
| LC4 | In distribution | |
| LT4 | In distribution | |
| LW5 | In distribution | |
| LS4 | In distribution | |
| LW4 | In distribution | |
| LX5 | In distribution | |
| LT4 | In distribution | |
| LT5 | In distribution | |
| RP | In distribution | |
| LW5 | In distribution | |
| LP5 | In distribution | |
| LP5 | In distribution | |
| LP4 | In distribution | |
| LT5 | In distribution | |
| LW4 | In distribution | |
| LS5 | In distribution | |
| LT4 | In distribution | |
| LP4 | In distribution | |
| LC4 | In distribution | |
| LC5 | In distribution | |
| LX4 | In distribution | |
| LC5 | In distribution | |
| LW4 | In distribution | |
| LP5 | In distribution | |
| LT4 | In distribution | |
| LW5 | In distribution | |
| LC5 | In distribution | |
| LX5 | In distribution | |
| LS4 | In distribution | |
| LS4 | In distribution | |
| LC4 | In distribution | |
| LS4 | In distribution | |
| LT5 | In distribution | |
| LX4 | In distribution | |
| LX5 | In distribution | |
| LC4 | In distribution | |
| LS5 | In distribution | |
| LC5 | In distribution | |
| LT5 | In distribution | |
| RP | In distribution | |
| LP4 | In distribution | |
| LS5 | In distribution | |
| LT5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 152 |
| Forest | Ls Enterprises, Inc. | 93 |
| 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 |
| Clesta LED Dental Light | Takara Belmont Corporation | 9 |
Showing 12 of 42. All products under Light, Operating, Dental
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-05-27 | Not classified | Device Design | Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient. | 13,226 units distributed worldwide | 2012-10-24 |
| 2007-05-01 | Not classified | Other | Potential for light shield to melt due to light assemblies not properly rated to handle the VAC. | 4 dual track lights | 2007-07-12 |
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.