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K Number
K071981
Device Name
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
Manufacturer
BONART CO. LTD.
Date Cleared
2007-10-26

(100 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

ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,

Device Description

BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the Bonart Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips). It does not contain information about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include details of performance testing or clinical studies that would be necessary to answer your questions.

§ 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.