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510(k) Data Aggregation

    K Number
    K170896
    Manufacturer
    Date Cleared
    2017-06-29

    (94 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Base in class I and II cavities
    • Cavity lining under direct restorative materials in class I and II cavities
    • Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
    • Class III and V restorations
    • Extended fissure sealing
    • Undercut blockout
    • Repair of small enamel defects
    • Repair of small defects in aesthetic indirect restorations
    • Repair of temporary C&B-materials
    • Core build-up
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to VOCO GmbH regarding their device, Admira Fusion x-base. This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain information about acceptance criteria, study methodologies, device performance data, sample sizes, or expert qualifications for testing.

    Therefore, I cannot provide the requested information based on the input text. The document confirms the device's classification and lists its intended uses but does not detail the studies or data used to support its safety and effectiveness.

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