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510(k) Data Aggregation

    K Number
    K973388
    Device Name
    DENTIN CONDITIONING AND ADHESIVE (BOND 1)
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    1997-09-12

    (3 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DENTIN CONDITIONING AND ADHESIVE (BOND 1)

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

    Adhesion to Dentin Of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, sami precious, and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental product called "Bond 1". It indicates that the device is substantially equivalent to existing devices. However, it does not contain any information regarding acceptance criteria or the specific studies used to prove device performance.

    Therefore, I cannot provide the requested information based on the input text. The document primarily focuses on regulatory approval and classification, not on the detailed technical specifications and performance data of the device.

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