BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ormco Corporation

    Reg #: 3013508670 · FEI: 2024258 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    45
    Establishment Types
    3
    Classifications
    32

    Registration Details

    Registration Name
    Ormco Corporation
    Registration Number
    3013508670
    FEI Number
    2024258
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1937 W. Mission Blvd.
    City
    Pomona
    State
    CA
    ZIP
    91766
    Country
    US

    Regulatory Submissions

    510(k) Number
    K943245

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

    Proprietary Names

    CLAMP WIRE ORTHODONTIC EndoRing SimpliCore Universal Verifier SimpliCore Verifier for Zenflex One Spark Clear Aligner System Water Cooled Impression Tray Originate Impression Trays Putty Spacer Three-In-One Impression Trays Clear Impression Trays Ormco Digital Bonding 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 Disposable Applicators Brushes Lythos

    Establishment Types

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