BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    KeyPrint KeySplint Soft

    DI: 00810002220173 · Model: 3014680794 · JOHN'S DENTAL LABORATORY INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KeyPrint KeySplint Soft
    Primary DI
    00810002220173
    Version / Model
    3014680794
    Company Name
    JOHN'S DENTAL LABORATORY INC
    Labeler DUNS
    016649253
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-04
    Public Version
    2
    Public Version Date
    2023-07-12
    Public Version Status
    Update
    Public Device Record Key
    09b06cad-4a69-4ca9-8d87-38a8b29ffeb7
    Distribution End Date
    2023-07-06

    Device Description

    The KeyPrint KeySplint Soft device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.

    Device Characteristics

    Single Use
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQC Mouthguard, Prescription
    KMY Positioner, Tooth, Preformed

    GMDN Terms

    Code Name
    16730 Dental appliance fabrication material, resin

    Identifiers

    Type ID
    Primary 00810002220173