BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENGINEERED ENDODONTICS

    Reg #: 3012322979 · FEI: 3012322979 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    ENGINEERED ENDODONTICS
    Registration Number
    3012322979
    FEI Number
    3012322979
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    W134N4965 Campbell Dr
    City
    Menomonee Falls
    State
    WI
    ZIP
    53051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212563

    Owner / Operator

    Firm Name
    Engineered Endodontics
    Operator Number
    10052002
    Address
    W134 N4965 Campbell Dr.
    City
    Menomonee Falls
    State
    WI
    Postal Code
    53051
    Country
    US
    Correspondent
    Mark Fiorina

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF
    Bur, Dental EJL
    Drill, Dental, Intraoral DZA
    File, Pulp Canal, Endodontic EKS
    Scaler, Ultrasonic ELC
    Preparer, Root Canal Endodontic EKQ
    Post, Root Canal ELR
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Liner, Cavity, Calcium Hydroxide EJK

    Proprietary Names

    EndoScout Z style Bur Munce Discovery Burs EndoScout Diamond Access bur EndoScout Multi Use Bur Munce TruGrit Filpin Drill Finishing File tun ultrasonic tip Filpost Irrigator Filpin ActaCal Paste

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device