BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SciPharm Gel Etch Dental Conditioner

    DI: D801SP7012B1 · Model: SP 70-12 B · SCIENTIFIC PHARMACEUTICALS, 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
    SciPharm Gel Etch Dental Conditioner
    Primary DI
    D801SP7012B1
    Version / Model
    SP 70-12 B
    Catalog Number
    70-12
    Company Name
    SCIENTIFIC PHARMACEUTICALS, INC.
    Labeler DUNS
    096010525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-10
    Public Version
    4
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    e3225d65-180a-4f8b-9ac1-0fbc104a731c

    Device Description

    Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Syringe. Boxed.

    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
    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
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    36153 Dental tooth-etching solution

    Identifiers

    Type ID
    Primary D801SP7012B1

    Customer Contacts

    Phone
    800-634-3047
    Email
    [email protected]
    Phone
    909-595-9922
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K872569 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 83 Degrees Fahrenheit