Coltolux
Charger Base w/ Power Supply, International Units
7manufacturers in China registered for this device type
27catalogue numbers in this listing
3510(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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K040551 |
| Record published | 2016-06-07 |
| Record revised | 2024-11-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 10 to 40 °C |
| Sizes | Lumen/inner diameter 8 to 13 mm; outer diameter 8 to 13 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C7970RK2 | In distribution | ||
| C7922 | Outer Diameter 11 mm | In distribution | |
| C7957 | 1,000 | In distribution | |
| C7945 | Lumen/Inner Diameter 13 mm | In distribution | |
| C7944 | Lumen/Inner Diameter 11 mm | In distribution | |
| C7944 | Lumen/Inner Diameter 11 mm | 100 | In distribution |
| C7972 | In distribution | ||
| C7990 | In distribution | ||
| C7925 | In distribution | ||
| C7964 | In distribution | ||
| C7921 | Outer Diameter 8 mm | In distribution | |
| C7924 | Lumen/Inner Diameter 8 mm | 100 | In distribution |
| C7972 | 25 | In distribution | |
| C7970230240 | In distribution | ||
| C7924 | Lumen/Inner Diameter 8 mm | In distribution | |
| C7970100115P | In distribution | ||
| C7966 | 2 | In distribution | |
| C7970100115 | In distribution | ||
| C7945 | Lumen/Inner Diameter 13 mm | 100 | In distribution |
| C7964W11MM | In distribution | ||
| C7923 | Outer Diameter 13 mm | In distribution | |
| C7970RK1 | In distribution | ||
| C7964M | In distribution | ||
| C7928 | 2 | In distribution | |
| C7990 | 25 | In distribution | |
| C7974 | 25 | In distribution | |
| C7974 | 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 |
| 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 |
| Light Guide | Kerr Corporation | 13 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040551 | 2004-03-15 |
| K945698 | 1995-05-24 |
| K950106 | 1995-05-24 |
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.