BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Park Dental Research Corp.

    DI: D7692015XO0 · Model: 2015-XO · PARK DENTAL RESEARCH CORP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Park Dental Research Corp.
    Primary DI
    D7692015XO0
    Version / Model
    2015-XO
    Company Name
    PARK DENTAL RESEARCH CORP
    Labeler DUNS
    011441508
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-16
    Public Version
    4
    Public Version Date
    2018-11-14
    Public Version Status
    Update
    Public Device Record Key
    e6eb0a6d-bbe8-4f06-a602-1b8e4837f72a

    Device Description

    2.0 mm x 15 mm LEW Mini Implant Non-collared

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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
    No

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    55848 Screw endosteal dental implant, one-piece

    Identifiers

    Type ID
    Primary D7692015XO0

    Customer Contacts

    Phone
    1-800-243-7372
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K121707 000