VA170-SC
Catalogue number VA170-SC, listed by Nakanishi Inc., Japan, under Scaler, Ultrasonic. 14 manufacturers in China are registered for 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 | Nakanishi Inc., Japan |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K113530 |
| Record published | 2026-02-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VA170-SC | 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 |
| Henry Schein | Henry Schein, Inc. | 48 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
Showing 12 of 653. All products under Scaler, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260773 | 2026-03-10 |
| K251689 | 2025-09-19 |
| K113717 | 2013-03-05 |
| K113530 | 2013-01-31 |
| K071447 | 2008-04-18 |
| K062731 | 2007-05-01 |
| K031421 | 2004-03-26 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-07-08 | Class II | Error in labeling | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are | 30719 units | 2018-06-25 |
| 2016-07-08 | Class II | Error in labeling | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are | 2574 units | 2018-06-25 |
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.