BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Standard Plus Implant

    DI: 06947600300007 · Model: 011010 · BIO CONCEPT Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Standard Plus Implant
    Primary DI
    06947600300007
    Version / Model
    011010
    Company Name
    BIO CONCEPT Co., Ltd.
    Labeler DUNS
    527603266
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-07
    Public Version
    6
    Public Version Date
    2024-12-05
    Public Version Status
    Update
    Public Device Record Key
    18e0e270-dc3e-4991-9196-bf97e847f794
    Distribution End Date
    2018-12-05

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NHA Abutment, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    55847 Dental implant system

    Identifiers

    Type ID
    Primary 06947600300007

    Premarket Submissions

    Submission Number Supplement Number
    K150388 000