BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    s-Clean TiN Half Coating Angled Abutment

    DI: 08806169115652 · Model: DSAA502527NHCT · DENTIS CO. ,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    s-Clean TiN Half Coating Angled Abutment
    Primary DI
    08806169115652
    Version / Model
    DSAA502527NHCT
    Company Name
    DENTIS CO. ,LTD
    Labeler DUNS
    694721181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-23
    Public Version
    6
    Public Version Date
    2021-05-26
    Public Version Status
    Update
    Public Device Record Key
    122d7792-ebbd-4815-b73d-2e8a9af42526

    Device Description

    Dental Implant System / s-Clean TiN Half Coating Angled Abutment D5.0mm, Cuff1.8mm, Angulation25° / Non-Hex

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    55849 Screw endosteal dental implant, two-piece

    Identifiers

    Type ID
    Primary 08806169115652

    Premarket Submissions

    Submission Number Supplement Number
    K171694 000