BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMERICAN ORTHODONTICS

    Reg #: 2126683 · FEI: 2126683 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    206
    Establishment Types
    4
    Classifications
    35

    Registration Details

    Registration Name
    AMERICAN ORTHODONTICS
    Registration Number
    2126683
    FEI Number
    2126683
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3524 Washington Ave
    City
    SHEBOYGAN
    State
    WI
    ZIP
    53081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K961417

    Owner / Operator

    Firm Name
    AMERICAN ORTHODONTICS
    Operator Number
    2126683
    Address
    3524 Washington Avenue, --
    City
    Sheboygan
    State
    WI
    Postal Code
    53081
    Country
    US

    Products

    Device Name Product Code
    Spring, Orthodontic ECO
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Band, Material, Orthodontic DYO
    Wax, Dental, Intraoral EGD
    Band, Preformed, Orthodontic ECM
    Tube, Orthodontic DZD
    Agent, Tooth Bonding, Resin KLE
    Wire, Orthodontic DZC
    Floss, Dental JES
    Material, Impression ELW
    Cement, Dental EMA
    Facebow KCR
    Material, Tooth Shade, Resin EBF
    Headgear, Extraoral, Orthodontic DZB
    Bracket, Ceramic, Orthodontic NJM
    Instrument, Ligature Tucking, Orthodontic ECP
    Bur, Dental EJL
    Tray, Impression, Preformed EHY
    Maintainer, Space Preformed, Orthodontic DYT
    Instruments, Dental Hand DZN
    Bracket, Metal, Orthodontic EJF
    Positioner, Tooth, Preformed KMY
    Protector, Dental BRW
    Gauge, Depth, Instrument, Dental EIL
    Band, Elastic, Orthodontic ECI
    Plier, Orthodontic JEX
    Bracket, Plastic, Orthodontic DYW
    Clamp, Wire, Orthodontic ECN
    Mirror, Mouth EAX
    Retractor, All Types EIG
    Retainer, Screw Expansion, Orthodontic DYJ
    Activator, Ultraviolet, For Polymerization EBZ
    Toothbrush, Manual EFW
    Cotton, Roll EFN
    Pusher, Band, Orthodontic ECS

    Proprietary Names

    Kilroy Spring Ulysses/Extrusion Spring Stainless Steel Springs Auxiliary Light Torquing Arch Nickel Titanium Memory Springs NiTi Springs Rotation Spring Compliance Spring Separating Spring Uprighting Spring Warren ART® Auxiliary Spring Porcelain Conditioner Band Material Orthodontic Wax Laminated Bite Wafers Debond Wafers Ortho Wax Bites Eagle Spectrum™ Eagle FluorSure Eagle No Drift™ Rollo Bands Mini Skirt Crowns MR Anteriors Contoured MRX Bands MR1 MR2 Master Series Slim Tube Inconel iFit Empower LP Low Profile Mini Master Series Nola Buccal Tube Empower 2 Dr. Korn Tube Convertible Singel Funneled Entrance Non Convertible Triple DB Tube Gold Convertible Triple PIggyback Tubes Non Convertible Lip Bumper Convertible Double Non Convertible WRAPAROUND Cross Tubes Non Convertible Non Convertible Double Iconix BracePaste Prime Plus Tanzo Ball Retainer Clasps Ligature Wire Beta Titanium Wire Everwhite Wire Force Two NiTi Wire Wrap Around Hawley Retainer Multiphase Blue Chromium Cobalt Wire Stainless Steel Wire Tritanium Therma-Ti Superelastic Titanium Memory Stainless Steel Retainer Wire Kobayashi Hooks Orientation Pin Therma-Ti "D" Therma-Ti Lite Power Pin Stainless Steel Multi-Strand NT3 Platypus Orthodontic Flosser Impressa/Chrome™ Bandtite Glass Ionomer Cement 300 Series Facebows Acid Etching (Gel, Semi-Gel, Liquid) EAGLEWEAR; Radiance Plus® BracePaste Fluoride Sealant Bandtite™ Band Cement Acid Etchant Ligating Instruments(Ligature Director, Single End Explorer, Force Module Separator, Ligature Tying Pliers, Wire Seater) Ligating Instruments (Mathieu Needle Holder, Smaha Forceps, Hemostat) No Mix: 30™ Impressa/Sure™ Carbide Bur Bur Kit Diamond Bur Empower Clear®, Empower® 2 Clear BracePaste Band And Build LC Impression Tray Tongue Director Bite Blocks Bondable Space Maintainer Bondable Retainer MR Lock LC™ Band Slitting Instrument Empower Instrument Specialty Instruments (Band Seater/Cement Scaler) Specialty Instruments (Adhesive Remover) Specialty Instruments (Wire Cutter) Bracket & Band Placing Instrument (Direct Bond Bracket Holders, Band Seater) AO Instruments - Open/Closer AO Instruments - Scaler, Band Pusher Specialty Instruments (Mouth Mirror) Specialty Instruments (Bracket Placement Guide) Luno™ (Debond) Bracket & Band Placing Instrument (Band Pusher) Specialty Instruments (Convertible Cap Remover, Spatula) Bracket & Band Placing Instrument (High Heat Bite Stick, Tweezers) Hex Head Driver 20/40 Ceramic Brackets™ (Roth, McLaughlin-Bennett-Trevisi (MBT), Standard Edgewise) Stealth Lingual T3 Forever Gold 24K Forever Gold Metal Custom Rx Mini Tweed Mini Standard Edgewise SL Stainless Steel Bracket atmos® material - tooth positioner, Vero BracePaste Bracepaste - Color Change Ultra-Guard Mouthguard Specialty Instruments (Boone Gauge) Specialty Instruments (Force Gage) The Wildlife Series Clear Rotation Wedges E-Z Tie Tubing Plastic Tie Sea Life Elastics Arch Wire Sleeve Memory Chain Tubing Separators Colored Chain Ligatures Elastic Placers Textured Thread Wire Bending Pliers Luno (Cutters, Band Remover) Luno (Pliers) Silkon Plus™ BracePaste MTP Light Cure Primer Protraction Face Mask Crimpable Stop Weldable Stop Monkey Hook Buttons Arch Lock Surgical Hook Lingual Sheaths Coil Eyelet Seating Lugs Ball Hook Eruption Appliance Power Hook Ball Hooks Elastic Lugs Ceramic Button Auxillary Hook Low Profile Cleats Gull Wing Cleats Eyelets UT Hook Arch Hook Cleo Photographic Mirror Clear Cheek Retractors American Cheek Retractors Uprighter Jet Gentle Jumper Palatal Arches Cantilever Bar Offset Mesial Jet Quick Fix (re-order components) Alexander Lip Bumper Rapid Molar Intruder Lip Bumper Jones Jig™ (re-order components) Rapid Molar Intruder (re-order components) Quad Helix Hanks Telescoping Herbst® Jones Jig™ Mandibular Advancer Powerscope™ 2 Distal Jet Spring Jet Spring Jet 1, Spring Jet 2 IOA Inter Occlusal Appliance Intraoral Expansion Screws Miniscope™ Telescoping Herbst® Jasper Jumper Quick Fix M.A.P. Mini Activator Posturer Herbst ™ Appliance Lip Bumper Reorder Components YC3 Shield / Muh Shield PowerBar Blue Ray 3 Platypus Orthodontic Toothbrush Cotton Roll Holders Aligner Seater Diastema

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)