Valo X
Valo X is a dental curing light for photo-activated restorative materials and adhesives. It provides a broad 380 to 515 nm spectrum and also supplies illumination for visual assistance…
Valo X is a dental curing light for photo-activated restorative materials and adhesives. It provides a broad 380 to 515 nm spectrum and also supplies illumination for visual assistance during oral procedures. It can operate from rechargeable Valo batteries or the supplied cord adapter.
The light can rest in a standard dental-unit bracket or use the included surface mounting bracket. Accessory lenses provide different functions, including directing curing light through translucent restorations, assisting proximal-contact shaping, comparing shades or viewing fluorescence in resin materials.
Listed Item
VALO X Loaner Unit Purple
Accessory-Lens Limits
The diffuser and other accessory lenses are not intended for complete curing of restorative materials or adhesives. White-light and black-light modes serve as diagnostic visual aids, while transillumination accessories help visualize teeth and prostheses. Their role differs from the curing light’s complete-restoration polymerization function.
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 | Ultradent Products Inc., United States |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K220471 |
| Record published | 2025-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5973-D | In distribution | |
| 6497-DU | In distribution | |
| 6519-LN | In distribution | |
| 6496-LN | In distribution | |
| 6497 | In distribution | |
| 6497-LN | In distribution | |
| 6498-DU | In distribution | |
| 6499-DU | In distribution | |
| 5973-DU | In distribution | |
| 6519-DU | In distribution | |
| 6538-DU | In distribution | |
| 6519 | In distribution | |
| 6496-DU | In distribution | |
| 6498-LN | In distribution | |
| 6499 | In distribution | |
| 6538 | In distribution | |
| 6496 | In distribution | |
| 6539 | In distribution | |
| 6498 | In distribution | |
| 6538-LN | In distribution | |
| 5973-LN | In distribution | |
| 6499-LN | 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 |
| 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 |
| Light Guide | Kerr Corporation | 13 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220471 | 2022-02-22 |
| K210550 | 2021-03-01 |
| K190627 | 2019-04-29 |
| K160551 | 2016-07-13 |
| K110582 | 2011-04-28 |
| K083647 | 2009-01-23 |
| K003383 | 2001-02-06 |
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.