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510(k) Data Aggregation

    K Number
    K123139
    Device Name
    ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    2013-03-28

    (174 days)

    Product Code
    ELC,DZI,EBZ,EFA,EIA,EKR,EKX,LQY
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

    The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law

    Device Description

    The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.

    AI/ML Overview

    I'm sorry, but this document does not contain the information required to fulfill your request. This appears to be an FDA 510(k) clearance letter for a dental treatment unit, not a study report or a document detailing acceptance criteria and device performance evaluation. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Information on sample sizes, data provenance, or details about test sets.
    • The number or qualifications of experts used to establish ground truth.
    • Adjudication methods.
    • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Details about the type of ground truth used (pathology, outcomes data, etc.).
    • Sample size for a training set or how ground truth for a training set was established.

    This document is a formal notification of market clearance based on substantial equivalence, not a detailed technical report of device validation.

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