BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SM3

    DI: 00814913029603 · Model: SM3 120V OPT · HIOSSEN, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SM3
    Primary DI
    00814913029603
    Version / Model
    SM3 120V OPT
    Company Name
    HIOSSEN, INC.
    Labeler DUNS
    796083090
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-20
    Public Version
    1
    Public Version Date
    2021-01-28
    Public Version Status
    New
    Public Device Record Key
    29859777-d8d1-43c3-bd94-f26946528454

    Device Description

    SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBW Controller, Foot, Handpiece And Cord
    KMW Handpiece, Rotary Bone Cutting
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

    GMDN Terms

    Code Name
    55847 Dental implant system

    Identifiers

    Type ID
    Primary 00814913029603

    Premarket Submissions

    Submission Number Supplement Number
    K173905 000