LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250222
    Device Name
    SDF Pro
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-05-07

    (100 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SDF Pro

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

    SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter for the SDF Pro device does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

    The letter's primary purpose is to confirm substantial equivalence of the SDF Pro to a legally marketed predicate device, allowing it to be marketed. It details:

    • Device Name: SDF Pro
    • Applicant: Belport Company, Inc., Gingi-Pak
    • Regulation Number and Name: 21 CFR 872.3260, Cavity Varnish
    • Regulatory Class: Class II
    • Product Code: PHR
    • Indications for Use: Intended to be used by dental professionals to treat tooth hypersensitivity in adults over the age of 21.

    Therefore, it is impossible to provide the requested information based on the provided text.

    The document is a clearance letter, not a summary of the technical or clinical performance data submitted for the clearance. Clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications, would typically be found in the original 510(k) submission document itself, which is not provided here.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1