Woodpecker
37 catalogue numbers from LED.X, listed by Guilin Woodpecker Medical Instrument Co., Ltd., China, under Activator, Ultraviolet, For Polymerization. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
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 | Guilin Woodpecker Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | EBZ |
| Device type | Activator, Ultraviolet, For Polymerization |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6070 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-10-20 |
| Record revised | 2025-12-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LED.X | In distribution | |
| LED.E PLUS | In distribution | |
| BUILT-IN H | In distribution | |
| LED.P、LED.L | In distribution | |
| LED.C | In distribution | |
| LED.Q | In distribution | |
| LED.B | In distribution | |
| LED.H | In distribution | |
| LED.M | In distribution | |
| LED.H | In distribution | |
| LED.M | In distribution | |
| LED.C | In distribution | |
| LED.G | In distribution | |
| iLed | In distribution | |
| LED.H正畸 | In distribution | |
| LED.E | In distribution | |
| LED.E | In distribution | |
| LED.F | In distribution | |
| LED.L | In distribution | |
| LED.B | In distribution | |
| LED.P | In distribution | |
| X-Cure | In distribution | |
| V V Light | In distribution | |
| LED.F | In distribution | |
| LED.G | In distribution | |
| LED.Q | In distribution | |
| BUILT-IN C | In distribution | |
| LED.K | In distribution | |
| O-Light II | In distribution | |
| LED.D | In distribution | |
| iLed | In distribution | |
| O-Light | In distribution | |
| LED.P | In distribution | |
| B-Cure | In distribution | |
| i Led II | In distribution | |
| LED.H正畸 | In distribution | |
| LED.D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valo | Ultradent Products Inc. | 59 |
| 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 |
| Light Guide | Kerr Corporation | 13 |
Showing 12 of 139. All products under Activator, Ultraviolet, For Polymerization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080025 | 2008-03-19 |
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.