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K Number
K062731
Device Name
ULTRASONIC SCALER, VARIOS 560
Manufacturer
NAKANISHI, INC.
Date Cleared
2007-05-01

(230 days)

Product Code
ELC
Regulation Number
872.4850
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device, Varios 560, an electric ultrasonic scaler, is intended for use with an appropriate tip for following use.

  • Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Scameg, Forto, Inprintin Mailier, Balishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Device Description

electric ultrasonic scaler

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an ultrasonic scaler. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot provide the requested information based on the provided text.

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.