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510(k) Data Aggregation

    K Number
    K014238
    Device Name
    DELSONIC 2000
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-01-24

    (29 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DELSONIC 2000

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

    The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system
    removal of light to h removal or light to tight to time for each scaling insert.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Delsonic 2000 Ultrasonic Scaler. It confirms that the device is substantially equivalent to a legally marketed predicate device.

    It does NOT contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    The content is primarily administrative, confirming FDA clearance and outlining general regulatory requirements.

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    K Number
    K990546
    Device Name
    DELSONIC 2000
    Manufacturer
    SDS DENTAL, INC.
    Date Cleared
    1999-11-05

    (256 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DELSONIC 2000

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

    The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.

    Device Description

    The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel

    AI/ML Overview

    The provided text is a 510(k) summary for the Delsonic 2000 Ultrasonic Scaler. It does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

    The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device (Dentsply). It describes the device, its intended use, and its classification. The subsequent pages are the FDA's response letter granting market clearance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is not present in this document.

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