D-LUX+
D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
7manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Diadent Group Intl., Inc., Canada |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K130163 |
| Record published | 2021-08-19 |
| Record revised | 2020-05-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 40 °C; Storage environment humidity 30 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Light Protector | In distribution | |
| HANDPIECE | In distribution | |
| CHARGER | In distribution | |
| D-Lux HANDPIECE | In distribution | |
| D-Lux CHARGER | In distribution | |
| BATTERY PACK | In distribution | |
| Regular Kit | In distribution | |
| LIGHT PROBE | In distribution | |
| D-Lux BATTERY PACK | In distribution | |
| REGULAR KIT | In distribution | |
| D-Lux LIGHT GUIDE (WHITE) | In distribution | |
| Power Cord | In distribution | |
| POWER SUPPLY (ADAPTER) | In distribution | |
| D-Lux LIGHT GUIDE (BLACK) | In distribution | |
| DISPOSABLE SHEATH | In distribution | |
| Light Probe Silicone Ring | 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 |
| Apoza | Apoza Enterprise Co., Ltd. | 15 |
| Soleil | Benco Dental Supply Co. | 15 |
| Light Guide | Kerr Corporation | 13 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200809 | 2020-08-07 |
| K130163 | 2013-08-16 |
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.