Coltolux Comfort
Coltolux Comfort is an LED curing light for dental restorative materials containing camphorquinone as the photoinitiator. It polymerizes compatible intraoral or extraoral composites,…
Coltolux Comfort is an LED curing light for dental restorative materials containing camphorquinone as the photoinitiator. It polymerizes compatible intraoral or extraoral composites, restoratives and dental adhesives.
A focused LED produces blue light in the 440 to 470 nm range. The clinician positions the lens close to the material and activates illumination with a pushbutton.
Listed Item
Coltolux Comfort KIT, International
Material Compatibility
The light is intended for materials whose curing chemistry responds to camphorquinone activation. Its role is to deliver the appropriate light to the restoration while the tip is held near the surface until curing is complete.
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 | DENT4YOU AG, Switzerland |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K223142 |
| Record published | 2023-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 38 °C; Handling environment humidity 15 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60034396 | 20 | In distribution | |
| 60034446 | In distribution | ||
| 60034394 | 5 | In distribution | |
| 60034395 | 5 | In distribution | |
| 60034390 | In distribution | ||
| 60034391 | In distribution | ||
| 60034392 | In distribution | ||
| 60034393 | 1,000 | 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 |
| Soleil | Benco Dental Supply Co. | 15 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223142 | 2022-12-22 |
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.