BEUDAMED
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    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·September 7, 2016

    ASAHI INTECC CO., LTD.

    Manufacturer
    🇯🇵 Japan·1371 Basic UDI-DIs·1371 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    GUNZE LIMITED

    Manufacturer
    🇯🇵 Japan·69 Basic UDI-DIs·69 Devices·3 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    TOP Corporation

    Manufacturer
    🇯🇵 Japan·39 Basic UDI-DIs·97 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    SEIKAGAKU CORPORATION

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    SB-KAWASUMI LABORATORIES, INC.

    Manufacturer
    🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Tokai Medical Products, Inc.

    Manufacturer
    🇯🇵 Japan·71 Basic UDI-DIs·71 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

    Sun Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·41 Basic UDI-DIs·55 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    JIMRO Co., Ltd.

    Manufacturer
    🇯🇵 Japan·3 Basic UDI-DIs·3 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    Asahi Polyslider Company, Limited

    Manufacturer
    🇯🇵 Japan·14 Basic UDI-DIs·17 Devices·SGS Belgium NV and SGS Belgium NV

    Takagi seiko

    Manufacturer
    🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

    PIOLAX MEDICAL DEVICES, INC.

    Manufacturer
    🇯🇵 Japan·22 Basic UDI-DIs·22 Devices·2 Importers·SGS Belgium NV

    Otsuka Electronics Co., Ltd.

    Manufacturer
    🇯🇵 Japan·6 Basic UDI-DIs·6 Devices·5 Importers·TÜV SÜD Product Service GmbH

    HAKKO CO., LTD.

    Manufacturer
    🇯🇵 Japan·2 Basic UDI-DIs·2 Devices·3 Importers·BSI Group The Netherlands B.V.

    Ziosoft, Inc.

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

    AIR WATER REALIZE INC.

    Manufacturer
    🇯🇵 Japan·55 Basic UDI-DIs·55 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

    Taiyo Nippon Sanso Corporation

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH

    TEIJIN MEDICAL TECHNOLOGIES CO., LTD.

    Manufacturer
    🇯🇵 Japan·188 Basic UDI-DIs·188 Devices·2 Importers·DEKRA Certification B.V.