BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHO ARCH COMPANY INC

    Reg #: 3007284437 · FEI: 3007284437 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    ORTHO ARCH COMPANY INC
    Registration Number
    3007284437
    FEI Number
    3007284437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1107 Tower Road
    City
    Schaumburg
    State
    IL
    ZIP
    60173
    Country
    US

    Regulatory Submissions

    510(k) Number
    K973776

    Owner / Operator

    Firm Name
    ORTHO ARCH COMPANY INC
    Operator Number
    10030081
    Address
    1107 Tower Road
    City
    Schaumburg
    State
    IL
    Postal Code
    60173
    Country
    US
    Correspondent
    Jonathan Leng

    Products

    Device Name Product Code
    Mouthpiece, Saliva Ejector DYN
    File, Pulp Canal, Endodontic EKS
    Spring, Orthodontic ECO
    Applicator, Resin KXR
    Cutter, Wire HXZ
    Toothbrush, Manual EFW
    Clamp, Wire, Orthodontic ECN
    Bracket, Plastic, Orthodontic DYW
    Wire, Orthodontic DZC
    Mirror, Mouth EAX
    Forceps, Tooth Extractor, Surgical EMG
    Activator, Ultraviolet, For Polymerization EBZ
    Gauge, Depth, Instrument, Dental EIL
    Wax, Dental, Intraoral EGD
    Marker, Periodontic EMP
    Plier, Orthodontic JEX
    Tube, Orthodontic DZD
    Instrument, Ligature Tucking, Orthodontic ECP
    Retractor, All Types EIG
    Band, Elastic, Orthodontic ECI
    Scissors, Surgical Tissue, Dental EGN
    Positioner, Tooth, Preformed KMY
    Instruments, Dental Hand DZN
    Patient Personal Hygiene Kit NSB
    Bracket, Ceramic, Orthodontic NJM
    Floss, Dental JES
    Aligner, Bracket, Orthodontic ECQ
    Bracket, Metal, Orthodontic EJF

    Proprietary Names

    Cottonmouth Dry Field System Root Canal Files Constant Force Nitinol Spring GTS Springs Mini-Molds CUTTER, WIRE Patient Care Kits, Travel Toothbrush, Disposable Toothbrush Composite Direct Bond Button Lingual Sheaths, Lingual Cleats (Weldable and Direct Bond) Crimpable Hook Coated COMPOSITE DIRECT BOND BUTTON Turbo-8 Braid SE Niti Black Satin SE Niti HA Niti with Copper SS Nic-O-Loy Keyhole 4-Loop Retraction Arch, SS T-Loop Retraction Arch, Beta-Titanium Mushroom-Loop Retraction Arch Pre-Torqued SE Niti HA Niti Finishing Performed Ligature Wire, Toothtone Ligature Wire, Shorty Ligature Ties, Kobyashi Tie Hooks D2 Appliance Posted SS Archwire, SS Cuspid-Loop Retraction Arch, AJ Wilcock Vertical-Loop Retraction Arch Shorty Kobyashi Hooks Stainless Steel, SS Multi-Stranded Leveling, SS Keyhole 2-Loop Retraction Arch, SS Keyhople 4-Loop Retraction Arch Multi Modulus (Multi-Force) HA Niti Heat Activated Niti SE Nitinol Wire Beta Titanium AJ Wilcock Australian Wire 25" Spool and 14" Length Wire Reverse Curve of Spee SE Niti and RSC (Straight Leg) SE Niti Brehm Niti Utility Arch Nano Coated Super Elastic Nitinol Archwires Super Glass Mirror: Occlusal, Lingual and Buccal Patient Care Kits Disposable Mirrors EZ Out Elevators Fusion Curing Light REDI SET LED LIGHT IPR Patient Relief Wax Patient Care Kits Patient Relief Wax Arch Markers SLB Easy Opening Instrument Buccal Tubes Pin & Ligature Cutter, Mini Ligature Cutter Photo Lip Retractor, Double Ended Lip Retractor, Expando Cheek Retractor, Access Cheek Retractor, Lip Retractor Glide-Ties, Elastic Chains, Elastomeric Separators Elastomeric Tissue Guard, Elastomeric Thread & Tubing, Rotation Wedges Amber Interoral Elastics, Rainbow Interoral Elastics, Non-Latex Clear Interoral Elastics Aligner Scissors Sport Mouthguard Elastic Attachers, Band Pusher, Band Seater Patient Care Kits Nova C, Nova S Patient Care Kits, Floss Vanish Twin, Vanish SLB Reverse Action Keat Molar Tube Placer Micro Twin Horizon Twin Conlin Nustar Self Ligating

    Establishment Types

    Repack or Relabel Medical Device