BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ETCH ROYALE™ DENTAL ETCHING GEL

    DI: D701ER12G2 · Model: ER12G · PULPDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ETCH ROYALE™ DENTAL ETCHING GEL
    Primary DI
    D701ER12G2
    Version / Model
    ER12G
    Company Name
    PULPDENT CORPORATION
    Labeler DUNS
    001006089
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-11
    Public Version
    3
    Public Version Date
    2019-11-26
    Public Version Status
    Update
    Public Device Record Key
    36225ddb-397d-4b25-936c-bbffe8448be8
    Distribution End Date
    2016-11-01

    Device Description

    12 gm (8.7 mL) syringe 37% Phosphoric Acid

    Device Characteristics

    Single Use
    No
    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
    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 etching solution

    Identifiers

    Type ID
    Primary D701ER12G2

    Device Sizes

    Type Value Unit Text
    Weight 12 Gram