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510(k) Data Aggregation

    K Number
    K972553
    Device Name
    LANG DENTAL RESIN A97 FIBRED PINK
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    1997-11-13

    (128 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LANG DENTAL RESIN A97 FIBRED PINK

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

    Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.

    Device Description

    Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental resin. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily focused on the substantial equivalence determination for the Lang Dental Resin A97 Fibred Pink.

    Therefore, I cannot extract the requested information as it is not present in the given text.

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