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510(k) Data Aggregation

    K Number
    K151123
    Device Name
    Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
    Manufacturer
    Pac-Dent International, Inc.
    Date Cleared
    2016-03-03

    (310 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132953,K962288
    Why did this record match?
    Device Name :

    Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

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

    Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.

    Device Description

    Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

    AI/ML Overview

    Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

    Device Name: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance Testing CategoryAcceptance Criteria (from predicate/recognized standards)Reported Device Performance
    Physical Properties
    Film ThicknessPredicate: 0.02mm, Tolerance:
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