BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premier

    DI: D6913001429 · Model: 3001429 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Premier
    Primary DI
    D6913001429
    Version / Model
    3001429
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2025-10-09
    Public Version Status
    Update
    Public Device Record Key
    9a5dff76-2233-45b9-a134-e223ccc42674

    Device Description

    Spot On Etch Sample 1.2ml syringe, 4 tips

    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
    Yes
    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 tooth-etching solution

    Identifiers

    Type ID
    Primary D6913001429

    Premarket Submissions

    Submission Number Supplement Number
    K131212 000