BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Japan ×

    DKK DAI-ICHI SHOMEI CO, LTD

    FDA registration
    DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan

    TWiNY Dentine DA1 2.6ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    TWiNY Dentine DA2 2.6ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    TWiNY Dentine DA2 Flow 2.0ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    TWiNY Dentine DA1 Flow 2.0ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luna-Wing Dentine DA2 3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luna-Wing Dentine DA1 3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luna-Wing Dentine DA0 3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    TWiNY Dentine Red Plus DA2 R 2.6ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    PreXion Corporation

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device

    JM Ortho Corporation

    Manufacturer
    🇯🇵 Japan

    J. MORITA TOKYO MFG. CORP.

    Manufacturer
    🇯🇵 Japan

    Luna-Wing Dentine A2 Flow DA2 Flow 2.3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·10 countries

    Luna-Wing Dentine Harmony Shade DA2 HS 3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    Luna-Wing Dentine A2 HS Flow DA2 HS Flow 2.3ml

    Device
    EU MDR · Eu Md Class 2a ·YAMAKIN CO., LTD.·On the market·11 countries

    ODONTOLOGY DEVICES - OTHER

    Device
    EU MDR · Eu Md Class 2b ·PreXion Corporation·No longer on the market

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024