BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TFRK-12

    Reg #: 3013022399 · FEI: 3013022399 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Dental Engineering Laboratories, LLC
    Registration Number
    3013022399
    FEI Number
    3013022399
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    315 Bollay Drive, Suite 150
    City
    Goleta
    State
    CA
    ZIP
    93117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122501

    Owner / Operator

    Firm Name
    Dental Engineering Laboratories
    Operator Number
    10052682
    Address
    315 Bollay Drive, Suite 150
    City
    Goleta
    State
    CA
    Postal Code
    93117
    Country
    US
    Correspondent
    William D Ingalls

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    TFRK-12 TFRK-6 TFRK-S ZTip-S ZTip-E

    Establishment Types

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