Cleared Traditional

K260773 - Varios Combi Pro2 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260773 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
1d
Days
Class 2
Risk

K260773 is an FDA 510(k) clearance for the Varios Combi Pro2. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on March 10, 2026 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K260773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2026
Decision Date March 10, 2026
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELC Scaler, Ultrasonic

All 194
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K260773.
GBT Machine Airflow Prophylaxis Master
K253254 · E.M.S Electro Medical Systems S.A · Jan 2026
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10)
K251689 · Nakanishi, Inc. · Sep 2025
Integrated Endo System (Meet Endo-II)
K242317 · Denjoy Dental Co., Ltd. · Feb 2025
OdneClean
K233844 · Odne AG · Aug 2024
Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
K240707 · Shenzhen Micro Electric Intelligence Co., Ltd. · Jul 2024
BioSonic US200 Ultrasonic Scaler (60034537)
K240801 · Dent4you AG · Jul 2024