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K Number
K162856
Device Name
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
Manufacturer
Bonart Co., Ltd.
Date Cleared
2017-07-18

(279 days)

Product Code
EGS
Regulation Number
872.4200
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations.

Device Description

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PERFORMANCE)

AI/ML Overview

The provided text is a 510(k) summary from the FDA for Bonart Dental Handpieces (ART) and Disposable Prophy Angle (PERFORMANCE). It is a letter of substantial equivalence and does not contain details about acceptance criteria, study methodologies, or performance results. This document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.