Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11)
FDA 510(k) K251689 · Nakanishi, Inc.
510(k) numberK251689
Submission
- Device name
- Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11)
- Applicant
- Nakanishi, Inc.
Kanuma, JP - Received
- June 2, 2025
- Decision date
- September 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELC
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|---|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | Nakanishi, Inc. | 03/10/2026SE |
| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | E.M.S Electro Medical Systems S.A | 01/28/2026SE |
| K242317 | Integrated Endo System (Meet Endo-II)ELC · Traditional | Denjoy Dental Co., Ltd. | 02/13/2025SE |
| K233844 | OdneCleanELC · Traditional | Odne AG | 08/08/2024SE |
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| K240801 | BioSonic US200 Ultrasonic Scaler (60034537)ELC · Traditional | Dent4you AG | 07/01/2024SE |
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | Satelec - Acteon Group | 03/11/2024SE |
| K223340 | EDS Calculus Softener TURBO CRELC · Traditional | Essential Dental Systems, Inc. | 12/11/2023SE |
| K230641 | Ultrasonic Scaler TipsELC · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/21/2023SE |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530)ELC · Traditional | W&H Dentalwerk Buermoss GmbH | 07/14/2023SE |
More from W&H Dentalwerk Buermoss GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | 03/10/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | 12/23/2025SE |
| K252662 | UniBurHBE · Traditional | 09/19/2025SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | 09/20/2024SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | 06/20/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | 04/25/2024SE |
| K230888 | Titanium TurbineEFB · Traditional | 06/02/2023SE |
| K230106 | General Cutting StraightEGS · Traditional | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | 11/17/2022SE |
Questions and answers
When was Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11) cleared by the FDA?
Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11) (K251689) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 109 days after the submission was received.
What is the product code of K251689?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.