BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dental Etchant (Enamel Conditioner), 12g Syringe

    DI: D83600400 · Model: 0040 · DENT ZAR, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Dental Etchant (Enamel Conditioner), 12g Syringe
    Primary DI
    D83600400
    Version / Model
    0040
    Catalog Number
    0040
    Company Name
    DENT ZAR, INC.
    Labeler DUNS
    789664455
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-04
    Public Version
    3
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    06c04889-e25c-4fc6-a380-969382e3bd09

    Device Description

    Etch Gel 12 g Syringe with disposable tips, also, available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips • Easy to wash off • Economical • Colored for precise application • Excellent wetting characteristics • Non-drying • Direct to tooth application with disposable luer-lock tips • Refillable applicator syringes

    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
    Yes
    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
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary D83600400