Henry Schein
Acclean Easy Grip XL Triple Bend Slim #1000 30K
14manufacturers in China registered for this device type
48catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| 510(k) | K053555 |
| Record published | 2025-01-15 |
| Record revised | 2019-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: No |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5702771 | In distribution | |
| 1126733 | In distribution | |
| 5701873 | In distribution | |
| 1126725 | In distribution | |
| 5703469 | In distribution | |
| 5703471 | In distribution | |
| 5702238 | In distribution | |
| 2020370 | In distribution | |
| 2020366 | In distribution | |
| 5701874 | In distribution | |
| 5702239 | In distribution | |
| 2020361 | In distribution | |
| 2020369 | In distribution | |
| 1126731 | In distribution | |
| 5701624 | In distribution | |
| 1126723 | In distribution | |
| 1047975 | In distribution | |
| 5701879 | In distribution | |
| 5701929 | In distribution | |
| 1126730 | In distribution | |
| 1126729 | In distribution | |
| 5701729 | In distribution | |
| 5703472 | In distribution | |
| 2020364 | In distribution | |
| 1126724 | In distribution | |
| 2020368 | In distribution | |
| 5703444 | In distribution | |
| 2020367 | In distribution | |
| 2020365 | In distribution | |
| 5702039 | In distribution | |
| 1126727 | In distribution | |
| 1126726 | In distribution | |
| 1126732 | In distribution | |
| 2020363 | In distribution | |
| 5702001 | In distribution | |
| 2020362 | In distribution | |
| 1126721 | In distribution | |
| 5702237 | In distribution | |
| 1126722 | In distribution | |
| 1126734 | In distribution | |
| 2020371 | In distribution | |
| 1126229 | In distribution | |
| 5702016 | In distribution | |
| 5701144 | In distribution | |
| 1126728 | In distribution | |
| 1049316 | In distribution | |
| 5701878 | In distribution | |
| 5702138 | 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 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 113 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 83 |
| Obtura Spartan | Obtura Spartan Endodontics | 74 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 45 |
Showing 12 of 653. All products under Scaler, Ultrasonic
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.