BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premium Teeth Resin - HT A2

    DI: 00860002099378 · Model: FLPTA201 · FORMLABS OHIO INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premium Teeth Resin - HT A2
    Primary DI
    00860002099378
    Version / Model
    FLPTA201
    Company Name
    FORMLABS OHIO INC.
    Labeler DUNS
    106744280
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-01
    Public Version
    1
    Public Version Date
    2024-02-09
    Public Version Status
    New
    Public Device Record Key
    b965b77f-6ada-40af-83fa-4dca3fda60a5

    Device Description

    Premium Teeth Resin is a light-curable nano-ceramic composite resin designed for the fabrication of 3D printed dental appliances, such as denture teeth for complete and partial removable dentures, try-in dentures, and provisional full-arch implant-supported restorations.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PZY Additively Manufactured, Preformed, Resin Denture Tooth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary 00860002099378