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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP

    K Number: K093084 · Decision Dec 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    5
    Review Days
    76

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    Basic Information

    Device Name
    ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
    K Number
    K093084
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rolence Ent., Inc.
    Date Received
    October 1, 2009
    Decision Date
    December 16, 2009
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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    Other Clearances by Rolence Ent., Inc.

    K Number Device Name
    K023545 ULTRA-LITE 200E LIGHT CURE UNIT
    K020877 EXCELLITE TURBO LIGHT CURE UNIT
    K020874 ULTRA-LITE 5 TURBO LIGHT CURE UNIT
    K020884 EXCELLITE LIGHT CURE UNIT