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510(k) Data Aggregation

    K Number
    K990739
    Device Name
    QUANTEC-E ENDO SYSTEM
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1999-05-26

    (82 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantec-E Endo System is an AC-powered unit consisting of a controller console, foot pedal and motor intended to be used in dentistry to drive dental handpieces.

    Device Description

    The device is an AC-powered unit consisting of a controller console, foot pedal and motor intended to be used in dentistry to drive dental handpieces. The motor has a maximum 1:1 drive output of 20,000 RPM's. This output can be geared up or down with the appropriate handpiece. The unit is supplied with both a 110V and 220V power cord. The entire motor assembly of the Quantec-E Endo System is autoclavable. The unit has an accessory port located on the rear panel of the device which may be used to attach accessory devices. One such device may include a pump that may deliver irrigation fluids.

    AI/ML Overview

    The provided text is a 510(k) summary for the Sybron Dental Specialties Quantec-E Endo System, an AC-powered dental handpiece. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not include acceptance criteria, performance data, or details of a study involving AI or human readers.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study results, as the provided text does not contain this type of data.

    To clarify why the information is not present:

    • Acceptance Criteria and Device Performance: The document states the device's description and intended use and claims substantial equivalence to another legally marketed device. It does not provide specific performance metrics (e.g., speed accuracy, torque output, durability standards) or acceptance criteria against those metrics.
    • Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): This is a premarket notification for a traditional medical device (a dental handpiece), not a software or AI-driven diagnostic device. As such, there is no discussion of clinical studies with AI, human readers, ground truth establishment, or associated methodologies. The regulatory approval here is based on demonstrating that the new device is functionally similar and safe as an existing, legally marketed device, not on proving new clinical performance.
    • Training Set Information: This is irrelevant for this type of device, which is hardware for mechanical operation rather than a learning algorithm.
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