BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Etch Gel (12 grams) with 25 tips

    DI: D876936060 · Model: 93606 · ALMORE INTERNATIONAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Etch Gel (12 grams) with 25 tips
    Primary DI
    D876936060
    Version / Model
    93606
    Catalog Number
    93606
    Company Name
    ALMORE INTERNATIONAL INC
    Labeler DUNS
    009051723
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-15
    Public Version
    2
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    4f2b2615-c2d2-4d14-ae9f-2aa87a997e91

    Device Description

    Etch Gel is a high viscosity enamel etching agent used for bonding purposes. It represents a 33% solution of ortho-phosphoric acid, thickened with a combination of water soluble and water dispersible agents. Simple to wash out and clean. Tinted for application control. Includes 1 Etch Gel Syringe (12 grams) and 25 applicator tips.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Expiration Date
    No
    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 D876936060