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510(k) Data Aggregation

    K Number
    K013555
    Device Name
    SCI-PHARM POST SECURE
    Manufacturer
    SCIENTIFIC PHARMACEUTICALS, INC.
    Date Cleared
    2002-01-23

    (90 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SCI-PHARM POST SECURE

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

    For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental cement product called "Sci-Pharm Post Secure." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    Crucially, this document is a regulatory approval letter and does not contain any information about acceptance criteria, study data, or performance metrics for the device. It's a notification of clearance, not a summary of a clinical or performance study.

    Therefore, I cannot provide the requested information based on the provided text. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device" and "determined the device is substantially equivalent." This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data itself is not present in this letter.

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