BEUDAMED
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    SIRONA MEDICAL, INC.

    FDA registration
    SIRONA MEDICAL, INC.·2 products·🇺🇸 United States

    Sirona Medical Radiology Platform

    FDA UDI
    Sirona Medical, Inc.·00860011175803·

    SURESMILE ALIGNER

    FDA Adverse Event
    Injury ·ORAMETRIX INC.·Product code NXC·January 31, 2019

    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Recall
    Open, Classified ·Dentsply IH, Inc.·Product code NDP·July 24, 2025

    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Recall
    Open, Classified ·Dentsply IH, Inc.·Product code NDP·July 24, 2025

    ORTHODONTICS HIGN DESIGN SRL

    Importer
    🇮🇹 Italy·4 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Ortho Organizers GmbH

    Importer
    🇩🇪 Germany·34 Manufacturers