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510(k) Data Aggregation

    K Number
    K060893

    Validate with FDA (Live)

    Device Name
    MODIFICATION TO REBILDA DC
    Manufacturer
    VOCO GMBH
    Date Cleared
    2006-05-25

    (52 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Special
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K143104
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Rebilda DC is intended for core build-up of vital and non-vital teeth

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document is a 510(k) clearance letter for a dental device (Rebilda DC) and does not contain the information you requested regarding acceptance criteria, study details, ground truth establishment, or sample sizes for an AI/ML device. This document is a regulatory approval, not a technical performance study report.

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