LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994172
    Device Name
    CEREC 3
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2000-02-08

    (60 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CEREC 3

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

    The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Sirona Dental Systems, GmbH, regarding the CEREC® 3 Ceramic Dental Restoration System. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, or comparative effectiveness studies. It is a regulatory approval letter that confirms the device can be marketed.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1