BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    6 x 8mm Simpli Simpler One Piece GBAE Dental Implant

    DI: D780S1S36080 · Model: S1S 3608 · Simpler Implant Solutions Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    6 x 8mm Simpli Simpler One Piece GBAE Dental Implant
    Primary DI
    D780S1S36080
    Version / Model
    S1S 3608
    Catalog Number
    S1S 3608
    Company Name
    Simpler Implant Solutions Inc
    Labeler DUNS
    203213343
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-11-06
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1c0f1e44-276b-4b20-934d-be17b8fa46e9

    Device Description

    6 x 8mm Simpli Simpler One Piece Grit Blasted Acid Etched Dental Implant for Crown and Bridge

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary D780S1S36080