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510(k) Data Aggregation

    K Number
    K021524
    Device Name
    LIGHT CURE DENTAL DAM
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2002-07-19

    (70 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIGHT CURE DENTAL DAM

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

    Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and moisture prevention/barrier.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Prime-Dent Light Cure Soft Dental Dam." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a technical performance report.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on presenting experimental data regarding the device's performance against defined acceptance criteria.

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