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510(k) Data Aggregation

    K Number
    K060270
    Device Name
    MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    2006-04-10

    (68 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K971059
    Why did this record match?
    Device Name :

    MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

    Device Description

    The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.

    The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device, the MicroPower Hand Piece: Oral Max High Speed Drill. It declares that the device is substantially equivalent to a previously cleared predicate device (Universal Drive System, K971059) and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence based on the device's design, intended use, and scientific technology being similar to a predicate device, rather than providing a performance study against acceptance criteria.

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