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    NEXUS / IPS GmbH

    Manufacturer
    🇩🇪 Germany

    PORTA IP SOLDER V-1

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTA IP SOLDER V-2

    FDA 510(k)
    FDA Class 2 ·Dental

    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

    FDA Enforcement
    Class II ·Terminated·Tec Com Gmbh·November 20, 2019

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices

    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

    FDA Enforcement
    Class II ·Terminated·Otto Bock Healthcare GmbH·November 11, 2015

    Dr. Franz Köhler Chemie GmbH

    Manufacturer
    🇩🇪 Germany

    Fette Pharma GmbH

    Manufacturer
    🇩🇪 Germany

    Murnauer Markenvertrieb GmbH

    Manufacturer
    🇩🇪 Germany

    DermaTools Biotech GmbH

    Manufacturer
    🇩🇪 Germany

    ImmuChrom GmbH

    Manufacturer
    🇩🇪 Germany

    LSK-Wintrich GmbH

    Manufacturer
    🇩🇪 Germany

    Dr. Wittmann GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device

    VEPRO AG

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH