Varios Combi Pro2
FDA 510(k) K260773 · Nakanishi, Inc.
510(k) numberK260773
Submission
- Device name
- Varios Combi Pro2
- Applicant
- Nakanishi, Inc.
Kanuma, JP - Received
- March 9, 2026
- Decision date
- March 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K242317 | Integrated Endo System (Meet Endo-II)ELC · Traditional | Denjoy Dental Co., Ltd. | 02/13/2025SE |
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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 |
|---|---|---|
| K254163 | VarioSurg 4DZI · Traditional | 12/23/2025SE |
| K252662 | UniBurHBE · Traditional | 09/19/2025SE |
| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · 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 Combi Pro2 cleared by the FDA?
Varios Combi Pro2 (K260773) received a 510(k) decision of Substantially Equivalent on March 10, 2026, 1 days after the submission was received.
What is the product code of K260773?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.