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K Number
K071447
Device Name
VARIOS 75
Manufacturer
NAKANISHI, INC.
Date Cleared
2008-04-18

(330 days)

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

This device, Varios 75, 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 Intervention / Finishing / Trimming / Polishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Device Description

Varios 75, an electric ultrasonic scaler

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device (Varios 75, an ultrasonic scaler). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on this document.

§ 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.