DTE
113 catalogue numbers from V2 LED, listed by Guilin Woodpecker Medical Instrument Co., Ltd., China, under Scaler, Ultrasonic. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
113catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (4), Shandong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Nanning Baolai Medical Instrument Co., Ltd. | Nanning | Guangxi | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic
Record
| Listed by | Guilin Woodpecker Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| Establishment | Manufacturer |
| 510(k) | K053555 |
| Record published | 2017-10-19 |
| Record revised | 2022-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V2 LED | In distribution | |
| PD41 | In distribution | |
| ED20D | In distribution | |
| PD41 | In distribution | |
| V6 | In distribution | |
| D7 LED | In distribution | |
| PD21R | In distribution | |
| V6 LED | In distribution | |
| D6 | In distribution | |
| PD20R | In distribution | |
| ED23D | In distribution | |
| PD20L | In distribution | |
| D7 | In distribution | |
| V1 | In distribution | |
| TD1 | In distribution | |
| ED24D | In distribution | |
| PD6T | In distribution | |
| PD11 | In distribution | |
| PD22L | In distribution | |
| D7 LED | In distribution | |
| D7 | In distribution | |
| ED7 | In distribution | |
| D1 | In distribution | |
| PD22R | In distribution | |
| D2 LED Plus | In distribution | |
| PD18 | In distribution | |
| V3 LED | In distribution | |
| D2 | In distribution | |
| 6 pieces of equipment | In distribution | |
| P7 | In distribution | |
| D3 LED | In distribution | |
| ED17 | In distribution | |
| PD8T | In distribution | |
| V3 | In distribution | |
| ED62 | In distribution | |
| S6 | In distribution | |
| HD-7H | In distribution | |
| U6 LED | In distribution | |
| D2 LED | In distribution | |
| PD21R | In distribution | |
| V2 | In distribution | |
| V3 | In distribution | |
| PD40 | In distribution | |
| ED93 | In distribution | |
| PD8 | In distribution | |
| ED60 | In distribution | |
| PT3 | In distribution | |
| ED24 | In distribution | |
| D3 | In distribution | |
| D1 | In distribution | |
| 5 pieces of equipment | In distribution | |
| ED19 | In distribution | |
| ED90 | In distribution | |
| ED23 | In distribution | |
| D600 | In distribution | |
| ED1、ED3 and so on | In distribution | |
| D5 LED | In distribution | |
| PT-B | In distribution | |
| TD5 | In distribution | |
| V2 LED | In distribution | |
| D6 LED | In distribution | |
| S6 LED | In distribution | |
| D5 LED | In distribution | |
| D5 | In distribution | |
| ED25LD | In distribution | |
| ED12 | In distribution | |
| ED18 | In distribution | |
| HD-7L | In distribution | |
| V1、V2、V2 LED、V3、V3 LED | In distribution | |
| HD-7 | In distribution | |
| ED22D | In distribution | |
| PT5 | In distribution | |
| D6 LED | In distribution | |
| ED25R | In distribution | |
| ED24 | In distribution | |
| ED66 | In distribution | |
| ED12D | In distribution | |
| D3 | In distribution | |
| PD7 | In distribution | |
| D8 LED | In distribution | |
| ED20 | In distribution | |
| PD42 | In distribution | |
| P7 LED | In distribution | |
| HD-1 | In distribution | |
| V6 LED | In distribution | |
| HD-5 | In distribution | |
| D4 | In distribution | |
| D6 | In distribution | |
| ED22 | In distribution | |
| D2 LED | In distribution | |
| ED90 | In distribution | |
| PT-A | In distribution | |
| D600 LED | In distribution | |
| D3 LED | In distribution | |
| D5 | In distribution | |
| D4 LED | In distribution | |
| ED19D | In distribution | |
| TD3 | In distribution | |
| TD4 | In distribution | |
| ED25RD | In distribution | |
| PD5 | In distribution | |
| V2 | In distribution | |
| ED25L | In distribution | |
| PD21L | In distribution | |
| GD12 | In distribution | |
| AP-B | In distribution | |
| ED12 | In distribution | |
| PD42 | In distribution | |
| HD-2L | In distribution | |
| TD2 | In distribution | |
| PD40 | In distribution | |
| TD6 | In distribution | |
| PD21L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 501 |
| Piezon | E.M.S. Electro Medical Systems S.A. | 245 |
| Acteon | Satelec | 236 |
| Mectron | Mectron SPA | 209 |
| Varios | Nakanishi Inc. | 158 |
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 142 |
| Cavitron® | Dentsply Professional | 137 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 83 |
| Obtura Spartan | Obtura Spartan Endodontics | 74 |
| Henry Schein | Henry Schein, Inc. | 48 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 45 |
Showing 12 of 653. All products under Scaler, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203615 | 2021-12-10 |
| K053555 | 2006-08-21 |
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.