BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORAPRO

    DI: 10817713020105 · Model: ETCHINKIT · ORTHOQUEST, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ORAPRO
    Primary DI
    10817713020105
    Version / Model
    ETCHINKIT
    Company Name
    ORTHOQUEST, INC.
    Labeler DUNS
    192699952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    b69b8243-cb86-43ed-93c0-e0fb2a3cbfe9

    Device Description

    ORTHQST ORAPRO ETCHANT SYR GREEN 4G

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    KLE Agent, Tooth Bonding, Resin

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary 10817713020105