BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)

• K Number: K052028
• Device Name: BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
• Manufacturer: BONART CO. LTD.
• Date Cleared: 2005-10-28 ( 93 days)
• Product Code: ELC
• Regulation Number: 872.4850
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K201317

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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.