Ultrasonic Scaler, Varios 560
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062731 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An ultrasonic scaler is a device that converts electrical energy into ultrasonic vibrations delivered through specialized tips to perform scaling, periodontal, endodontic, and restorative procedures. The Varios 560 is an electric ultrasonic scaler used in dental clinics by dental professionals.
The device is intended for use in dental offices only and generates ultrasonic waves for applications such as scaling, root canal treatment, periodontal therapy, and cavity preparation. It is supplied as a reusable system with specialized tips, and its regulatory status is based on FDA 510(k) clearance under product code ELC and regulation number 872.4850.
Frequently asked questions
What is the Varios 560 ultrasonic scaler used for?
The Varios 560 ultrasonic scaler is used to perform scaling, periodontal, endodontic, and restorative procedures by converting electrical energy into ultrasonic vibrations delivered through specialized tips, intended for use in dental offices only.
How is the Varios 560 ultrasonic scaler supplied and is it reusable?
The Varios 560 is supplied as a reusable system with specialized tips, meaning the main unit is designed for repeated use after proper cleaning and sterilization, while the tips may be single-use or reusable depending on the specific tip model and manufacturer instructions.
What regulatory pathway was used for the Varios 560 ultrasonic scaler?
The Varios 560 received FDA 510(k) clearance under product code ELC and regulation number 872.4850, indicating it was found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ULTRASONIC SCALER, VARIOS 560 (K062731) — FDA 510(k) | Innolitics, Varios Series | Oral Hygiene | NSK-Nakanishi USA, NSK VARIOS 560 LUX OPERATION MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062731 | Class II | Active |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- FDA Applicant
- Nakanishi, Inc.
Sources (1)
- FDA 510(k) K062731 24 fields · synced Sep 24, 2026