Soleil
Soleil LED Shield Snap-ON BX25
7manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Guangxi (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
Record
| Listed by | Benco Dental Supply Co. |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| 510(k) | K040551 |
| Record published | 2017-10-02 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 10 to 40 °C; Special storage condition: KEEP DRY |
| Packaging | Case of 100, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5128-185 | In distribution | |
| 4376-767 | In distribution | |
| 5118-383 | In distribution | |
| 3538-307 | In distribution | |
| 5128-265 | In distribution | |
| 3515-608 | In distribution | |
| 4376-758 | In distribution | |
| 5128-176 | In distribution | |
| 5128-774 | In distribution | |
| 3538-281 | In distribution | |
| 3538-290 | In distribution | |
| 5128-783 | In distribution | |
| 5118-347 | In distribution | |
| 5118-374 | In distribution | |
| 5118-392 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valo | Ultradent Products Inc. | 59 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 37 |
| Ledex | Dentmate Technology Co., Ltd. | 34 |
| Coltolux | Coltene/Whaledent Gmbh & Co. KG | 27 |
| Valo X | Ultradent Products Inc. | 22 |
| Spec 3 | Coltene/Whaledent Gmbh & Co. KG | 20 |
| Bluephase G4 | Ivoclar Vivadent Aktiengesellschaft | 20 |
| Aurora™ | Parkell, Inc. | 18 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 17 |
| D-LUX+ | Diadent Group Intl., Inc. | 16 |
| Apoza | Apoza Enterprise Co., Ltd. | 15 |
| Light Guide | Kerr Corporation | 13 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
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.