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·

    BA INTERNATIONAL 1:5 HANDPIECE

    FDA Adverse Event
    Injury ·B.A. INTERNATIONAL LTD.·Product code EGS·November 12, 2020

    SURESMILE ALIGNER

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

    VDW SILVER RECIPROCATING MOTOR

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EBW·January 9, 2020

    X-SMART PLUS

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·April 4, 2023

    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

    X-SMART W/CONTRA ANGLE EUR

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKX·February 12, 2026

    UNKNOWN XIVE IMPLANT

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·March 27, 2025

    **NUPRO REVOLV 90D SOFT MULTI (PD)

    FDA Adverse Event
    Malfunction ·DENTSPLY LLC·Product code EGS·June 25, 2025

    IMPLANT DRIVER EV (XL) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (L) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 19, 2025

    IMPLANT DRIVER EV (L) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (XL) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (XL) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 18, 2025

    IMPLANT DRIVER EV (S) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (XL) SHORT

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (XS) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025

    IMPLANT DRIVER EV (M) LONG

    FDA Adverse Event
    Malfunction ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·December 16, 2025