Varios
158 catalogue numbers from V10, listed by Nakanishi Inc., Japan, under Scaler, Ultrasonic. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
158catalogue numbers in this listing
7510(k) clearances naming this product code
2recalls on this 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 | 2016-09-16 |
| Record revised | 2026-01-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-12-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| V10 | In distribution | ||
| P25L | In distribution | ||
| P26R | In distribution | ||
| Scaling G16 Pack | 6 | In distribution | |
| E6 | In distribution | ||
| P41 | In distribution | ||
| P25R | In distribution | ||
| E32D | In distribution | ||
| P21L | In distribution | ||
| G6 | 6 | In distribution | |
| E5 | In distribution | ||
| G16 | In distribution | ||
| P40 | In distribution | ||
| P10 | In distribution | ||
| P11R | In distribution | ||
| P3D | In distribution | ||
| P2D | In distribution | ||
| G8 | 6 | In distribution | |
| E4D | In distribution | ||
| G61D | In distribution | ||
| V-S53 | 3 | In distribution | |
| P20 | In distribution | ||
| E9 | In distribution | ||
| V-S52 | 3 | In distribution | |
| G4 | 6 | In distribution | |
| E30RD | In distribution | ||
| P21R | In distribution | ||
| G65D | In distribution | ||
| G12 | In distribution | ||
| VA970 (120V) | In distribution | ||
| VA970 LUX(120V) | In distribution | ||
| V-P26L | 3 | In distribution | |
| G11 | In distribution | ||
| G6 | In distribution | ||
| E4 | In distribution | ||
| U files 33mm ISO 25 | 6 | In distribution | |
| G4 | In distribution | ||
| U files 33mm ISO 15 | 6 | In distribution | |
| E12 | In distribution | ||
| E7D | In distribution | ||
| P26L | In distribution | ||
| E31D | In distribution | ||
| E30LD | In distribution | ||
| CR-1 | In distribution | ||
| G2 | In distribution | ||
| E9D | In distribution | ||
| Varios 970 Unit NA | In distribution | ||
| P1 | In distribution | ||
| E11 | In distribution | ||
| G66D | In distribution | ||
| Endo Kit E12 | In distribution | ||
| Endo Kit E11 | In distribution | ||
| G68D | In distribution | ||
| U files 33mm ISO 35 | 6 | In distribution | |
| E8 | In distribution | ||
| G8 | In distribution | ||
| V-S50 | 3 | In distribution | |
| V-P26R | 3 | In distribution | |
| V-S51 | 3 | In distribution | |
| E8D | In distribution | ||
| P1D | In distribution | ||
| G67D | In distribution | ||
| G3 | In distribution | ||
| E15D | In distribution | ||
| G5 | In distribution | ||
| G1 | In distribution | ||
| E14D | In distribution | ||
| V30 | In distribution | ||
| U files 33mm ISO 30 | 6 | In distribution | |
| G62D | In distribution | ||
| E7 | In distribution | ||
| G1 | 6 | In distribution | |
| U files 33mm ISO 20 | 6 | In distribution | |
| G9 | In distribution | ||
| P11L | In distribution | ||
| G9 | 6 | In distribution | |
| G13 | In distribution | ||
| Varios 350 120V | Withdrawn | ||
| Varios 350 230V | Withdrawn | ||
| Varios 560 230V | Withdrawn | ||
| P25L-E | Withdrawn | ||
| V-S51D | 3 | Withdrawn | |
| V-S33 | 3 | Withdrawn | |
| Varios 750 120V | Withdrawn | ||
| VA370 (120V) | Withdrawn | ||
| P21L-E | Withdrawn | ||
| VA970 (120V) | Withdrawn | ||
| V-N50 | 3 | Withdrawn | |
| V-S50D | 3 | Withdrawn | |
| VA150 | Withdrawn | ||
| V-G76 | 3 | Withdrawn | |
| V-S1 | 3 | Withdrawn | |
| VA560 120V | Withdrawn | ||
| Varios 750 LUX 230V | Withdrawn | ||
| NE171 | Withdrawn | ||
| P25R-E | Withdrawn | ||
| VA150 | Withdrawn | ||
| G26 | Withdrawn | ||
| P10 | 6 | Withdrawn | |
| Varios 750 120V | Withdrawn | ||
| Varios 750 230V | Withdrawn | ||
| V-G79 | 3 | Withdrawn | |
| V-G75 | 3 | Withdrawn | |
| V-S3 | 3 | Withdrawn | |
| Varios 750 230V | Withdrawn | ||
| Varios 350 LUX 230V | Withdrawn | ||
| DA150SL | Withdrawn | ||
| NE133 | Withdrawn | ||
| Varios 970 Unit (120V) | Withdrawn | ||
| Varios 750 LUX 120V | Withdrawn | ||
| V-S52D | 3 | Withdrawn | |
| Varios 560 LUX 230V | Withdrawn | ||
| P21R-E | Withdrawn | ||
| Varios 560 LUX 120V | Withdrawn | ||
| V-N51 | 3 | Withdrawn | |
| V-G70 | 3 | Withdrawn | |
| Varios 750 LUX 120V | Withdrawn | ||
| G7 | Withdrawn | ||
| NE133 | Withdrawn | ||
| P20 | 6 | Withdrawn | |
| Varios 560 LUX 120V | Withdrawn | ||
| V-G77 | 3 | Withdrawn | |
| NE149 | Withdrawn | ||
| G2-E | Withdrawn | ||
| V-G78 | 3 | Withdrawn | |
| Tip Cap | 10 | Withdrawn | |
| Varios 750 120V | Withdrawn | ||
| Varios 350 120V | Withdrawn | ||
| NE149 | Withdrawn | ||
| G3-E | Withdrawn | ||
| G4-E | Withdrawn | ||
| VA150 | Withdrawn | ||
| V10-E | Withdrawn | ||
| G22 | Withdrawn | ||
| V-S53D | 3 | Withdrawn | |
| NE149 | Withdrawn | ||
| Varios 560 120V | Withdrawn | ||
| VA370 LUX (120V) | Withdrawn | ||
| VA150 LUX | Withdrawn | ||
| Varios 750 LUX 120V | Withdrawn | ||
| G6-E | Withdrawn | ||
| V-G71 | 3 | Withdrawn | |
| G1-E | Withdrawn | ||
| G25 | Withdrawn | ||
| V-G72 | 3 | Withdrawn | |
| Varios 750 120V | Withdrawn | ||
| Varios 350 LUX 120V | Withdrawn | ||
| Varios 350 LUX 120V | Withdrawn | ||
| VA150 LUX | Withdrawn | ||
| G28 | Withdrawn | ||
| Varios 750 120V | Withdrawn | ||
| VA970 LUX(120V) | Withdrawn | ||
| G21 | Withdrawn | ||
| P20-E | Withdrawn | ||
| VA150LUX BEL – NA | Withdrawn | ||
| Varios 350 Unit | Withdrawn | ||
| Varios 750 120V | Withdrawn | ||
| VA150 LUX | Withdrawn |
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 |
| 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 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 45 |
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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nakanishi Inc. | 510(k) number | 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 |
Recalls
1 of these is 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 | 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.