BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ormco Corporation

    Reg #: 3015272949 · FEI: 3015272949 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    73
    Establishment Types
    3
    Classifications
    37

    Registration Details

    Registration Name
    Ormco Corporation
    Registration Number
    3015272949
    FEI Number
    3015272949
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    200 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K923556

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1889 W Mission Blvd, --
    City
    Pomona
    State
    CA
    Postal Code
    91766
    Country
    US

    Products

    Device Name Product Code
    Band, Preformed, Orthodontic ECM
    Applicator, Resin KXR
    Spring, Orthodontic ECO
    Wax, Dental, Intraoral EGD
    Headgear, Extraoral, Orthodontic DZB
    Bracket, Ceramic, Orthodontic NJM
    Bracket, Metal, Orthodontic EJF
    Bracket, Plastic, Orthodontic DYW
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Cement, Dental EMA
    Mirror, Mouth EAX
    Plier, Orthodontic JEX
    Band, Elastic, Orthodontic ECI
    Instrument, Ligature Tucking, Orthodontic ECP
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Point, Paper, Endodontic EKN
    Pusher, Band, Orthodontic ECS
    Forceps HTD
    Orthodontic Software PNN
    Aligner, Sequential NXC
    Controller, Foot, Handpiece And Cord EBW
    Indirect Bonding Tray QJJ
    Agent, Tooth Bonding, Resin KLE
    Tray, Impression, Preformed EHY
    Gauge, Depth, Instrument, Dental EIL
    Remover, Crown EIS
    Instruments, Dental Hand DZN
    Setter, Band, Orthodontic ECR
    Wire, Orthodontic DZC
    Accessories, Implant, Dental, Endosseous NDP
    Clamp, Wire, Orthodontic ECN
    Implant, Endosseous, Orthodontic OAT
    Aligner, Bracket, Orthodontic ECQ
    Instrument, Cutting, Operative EKD
    Tube, Orthodontic DZD
    Maintainer, Space Preformed, Orthodontic DYT
    Gutta-Percha EKM

    Proprietary Names

    Disposable Applicators Brushes Bite Wafer Disclosing Wax Occlusal Indicator Wax TF Adaptive Paper Points K3/K3XF Paper Points ZenFlex ONE Paper Points TF Paper Points Autofit Paper Points PAPER POINTS Lythos Spark Clear Aligner System elements e-motion Ormco Digital Bonding Water Cooled Impression Tray Originate Impression Trays Putty Spacer Three-In-One Impression Trays Clear Impression Trays EndoRing SimpliCore Universal Verifier SimpliCore Verifier for Zenflex One Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips CLAMP WIRE ORTHODONTIC K3XF Gutta Percha Elements Gutta Percha Cartridge TF Adaptive Gutta Percha SoftCore TF Adaptive Obturator TF Adaptive Verifiers Gutta Percha Cartridge Zenflex Pre-Tip Gutta Percha Gutta Percha ZenFlex ONE Gutta Percha Autofit Backfill Gutta Percha SimpliCore Obturator Universal SimpliFill Apical Plugs SimpliCore Obturator for Zenflex One Autofit Gutta Percha K3 Gutta Percha Tip Snip- GP Gauge Wheel with Stand TF Gutta Percha

    Establishment Types

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