BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    High-Wave

    Reg #: 9613743 · FEI: 3002856975 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DENPLUS, INC.
    Registration Number
    9613743
    FEI Number
    3002856975
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333-M Chemin du Tremblay
    City
    Boucherville Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K011762

    Owner / Operator

    Firm Name
    DENPLUS, INC.
    Operator Number
    9038235
    Address
    333-M Chemin du Tremblay, --
    City
    Boucherville
    State
    Quebec
    Postal Code
    J4B 7M1
    Country
    CA
    Correspondent
    DENIS - NOEL

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    High-Wave Pour-Plus

    Establishment Types

    Manufacture Medical Device