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510(k) Data Aggregation

    K Number
    K032757
    Device Name
    A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2003-12-10

    (96 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The A-dec Self-Contained Water System is intended for use in providing water to the dental syringe, various handpiece devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental water system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a study as it pertains to medical device performance evaluation.

    This type of information is usually found in the 510(k) summary or the actual submission documents, which are not provided here. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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