BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OptiBond Universal

    Reg #: 2024312 · FEI: 2024312 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Kerr Corporation
    Registration Number
    2024312
    FEI Number
    2024312
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1717 W Collins Ave
    City
    ORANGE
    State
    CA
    ZIP
    92867
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060469

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1717 W. Collins Ave. Ca. 92867 USA, --
    City
    Orange
    State
    CA
    Postal Code
    92867
    Country
    US
    Correspondent
    Jennifer Evans

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    OptiBond Universal OptiBond All-In-One

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device