BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HE12 ECO LINE High Speed Handpiece

    Reg #: 3003114027 · FEI: 3003114027 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    66
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MK-dent GmbH
    Registration Number
    3003114027
    FEI Number
    3003114027
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Marie-Curie-Str. 2
    City
    Bargteheide Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032234

    Owner / Operator

    Firm Name
    MK-dent GmbH
    Operator Number
    10037735
    Address
    Marie-Curie-Str. 2
    City
    Bargteheide
    State
    Schleswig-Holstein
    Postal Code
    22941
    Country
    DE
    Correspondent
    Florian Kleene

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    HE12 ECO LINE High Speed Handpiece HP22WL PRIME LINE High Speed Handpiece with Light QC6116KW Quick Connector, 4 holes (6 pins) QC4014NT Quick Connector, 4 holes HB21K BASIC LINE High Speed Handpiece QC5016K Quick Connector, 4 holes (6 pins) HE14 ECO LINE High Speed Handpiece HE17B ECO LINE High Speed Handpiece HC22K CLASSIC LINE High Speed Handpiece HE22NL ECO LINE High Speed Handpiece with Light HE16L ECO LINE High Speed Handpiece with Light QC4012K Quick Connector, 2 holes HE20KL ECO LINE High Speed Handpiece with Light HE15L ECO LINE High Speed Handpiece with Light HP21KL PRIME LINE High Speed Handpiece with Light HB14 BASIC LINE High Speed Handpiece HP21SL PRIME LINE High Speed Handpiece with Light QC4014W Quick Connector, 4 holes HP22KL PRIME LINE High Speed Handpiece with Light HB15L BASIC LINE High Speed Handpiece with Light HP21WL PRIME LINE High Speed Handpiece with Light QC5116KW Quick Connector, 4 holes (6 pins) HE18 ECO LINE High Speed Handpiece HE20K ECO LINE High Speed Handpiece HE22K ECO LINE High Speed Handpiece QC6016NT Quick Connector, 4 holes (6 pins) HE17 ECO LINE High Speed Handpiece HB16L BASIC LINE High Speed Handpiece with Light QC5015K Quick Connector, 4 holes HB23K BASIC LINE High Speed Handpiece QC5016NT Quick Connector, 4 holes (6 pins) HE21N ECO LINE High Speed Handpiece QC4014K Quick Connector, 4 holes HC21K CLASSIC LINE High Speed Handpiece HE21WL ECO LINE High Speed Handpiece with Light HC20KL CLASSIC LINE High Speed Handpiece with Light QC5116K Quick Connector, 4 holes (6 pins) HE21W ECO LINE High Speed Handpiece HE11 ECO LINE High Speed Handpiece HP22NL PRIME LINE High Speed Handpiece with Light QC6116K Quick Connector, 4 holes (6 pins) HB12 BASIC LINE High Speed Handpiece HC8021K PRIME LINE High Speed Handpiece HP21NL PRIME LINE High Speed Handpiece with Light HB21KL BASIC LINE High Speed Handpiece with Light QC5016KW Quick Connector, 4 holes (6 pins) HC20K CLASSIC LINE High Speed Handpiece QC5016W Quick Connector, 4 holes (6 pins) HE21SL ECO LINE High Speed Handpiece with Light HC21KL CLASSIC LINE High Speed Handpiece with Light HE22N ECO LINE High Speed Handpiece HE22WL ECO LINE High Speed Handpiece with Light HB23KL BASIC LINE High Speed Handpiece with Light QC5016SW Quick Connector, 4 holes (6 pins) HE21NL ECO LINE High Speed Handpiece with Light HE22KL ECO LINE High Speed Handpiece with Light HC22KL CLASSIC LINE High Speed Handpiece with Light HE21K ECO LINE High Speed Handpiece QC6016SW Quick Connector, 4 holes (6 pins) QC6016K Quick Connector, 4 holes (6 pins) HE21KL ECO LINE High Speed Handpiece with Light QC6016KW Quick Connector, 4 holes (6 pins) HE22W ECO LINE High Speed Handpiece LU1031 Premium Service Oil LU1011 Premium Service Oil LU1022 Premium Service Oil

    Establishment Types

    Manufacture Medical Device