BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    American Dental Implant

    DI: D896TH5765030 · Model: TH57/6503 · AMERICAN DENTAL IMPLANT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Dental Implant
    Primary DI
    D896TH5765030
    Version / Model
    TH57/6503
    Catalog Number
    TH57/6503
    Company Name
    AMERICAN DENTAL IMPLANT CORPORATION
    Labeler DUNS
    835556429
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-31
    Public Version
    2
    Public Version Date
    2018-12-07
    Public Version Status
    Update
    Public Device Record Key
    badbbeeb-4285-45e2-a3cd-db1971e94e3d

    Device Description

    5.7/6.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck

    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
    44880 Dental implant suprastructure, temporary, preformed, single-use

    Identifiers

    Type ID
    Primary D896TH5765030

    Customer Contacts

    Phone
    8005110661
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K080397 000