LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091019
    Device Name
    SPEEDCEM
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2009-06-04

    (56 days)

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

    SPEEDCEM

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

    SpeedCem is indicated fo rthe Permanent cementation of indirect restorations made of:

    • metal and metal-ceramic (inlays, onlays, crowns, bridges, endodontic posts)
    • high-strength all-ceramic: zirconium oxide, lithium disilicate and aluminium oxide ceramics
    • (crowns, bridges, endodontic posts)
    • fibre-reinforced composite (endodontic posts)
    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) premarket notification letter for a dental cement called SPEEDCEM. It discusses the regulatory review process and confirms the device's substantial equivalence to other legally marketed predicate devices.

    The document does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1