BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prosthetic Accessories

    DI: 07290107274333 · Model: D2O-3.75,15 · A.B. DENTAL DEVICES LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prosthetic Accessories
    Primary DI
    07290107274333
    Version / Model
    D2O-3.75,15
    Catalog Number
    D2O-3.75,15
    Company Name
    A.B. DENTAL DEVICES LTD
    Labeler DUNS
    534128491
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-05
    Public Version
    2
    Public Version Date
    2020-09-22
    Public Version Status
    Update
    Public Device Record Key
    55e928b3-7926-40c1-a881-4e8dd3092fc1

    Device Description

    Impression Transfer for open tray, 3.75 mm Diameter, 15 mm length

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    61647 Dental prosthesis/implant abutment screw

    Identifiers

    Type ID
    Package 17290107274330
    Primary 07290107274333

    Customer Contacts

    Phone
    +972732454900
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132125 000