Varios Combi Pro2— 510(k) K260773
Substantially EquivalentNakanishi, Inc.
FDA 510(k) clearance K260773 for Varios Combi Pro2, Substantially Equivalent on 2026-03-10. Applicant: Nakanishi, Inc.. Device class: 2.
Summary
Nakanishi's Varios Combi Pro2 is filed under ELC, ultrasonic scalers. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 872.4850. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Nakanishi filed from Kanuma, Japan. The decision came 1 calendar day after receipt (March 9 to March 10, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Nakanishi, Inc.
- Product code
- Product code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kanuma, JP
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More clearances from Nakanishi, Inc.
view allAdverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.