BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KeyPrint KeySplint Hard

    Reg #: 3010002722 · FEI: 3010002722 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Keystone Industries - Gibbstown
    Registration Number
    3010002722
    FEI Number
    3010002722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    480 S Democrat Rd
    City
    Gibbstown
    State
    NJ
    ZIP
    08027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203000

    Owner / Operator

    Firm Name
    Keystone Industries
    Operator Number
    9007845
    Address
    480 S. Democrat Road, --
    City
    Gibbstown
    State
    NJ
    Postal Code
    08027
    Country
    US
    Correspondent
    Gloria - Zuclich

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC

    Proprietary Names

    KeyPrint KeySplint Hard

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device