BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AdDent

    DI: D8691120010 · Model: OraBlu · ADDENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AdDent
    Primary DI
    D8691120010
    Version / Model
    OraBlu
    Catalog Number
    112001
    Company Name
    ADDENT, INC.
    Labeler DUNS
    099490679
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ecf634f9-3b2d-4275-b788-f7f1ff02dfd7

    Device Description

    The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

    Device Characteristics

    Single Use
    No
    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NXV Diagnostic Light, Soft Tissue Detector

    GMDN Terms

    Code Name
    43595 Toluidine blue O solution IVD

    Identifiers

    Type ID
    Primary D8691120010

    Customer Contacts

    Phone
    2037780200
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K121282 000