BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RMO

    Reg #: 1718476 · FEI: 1718476 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    35

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    Registration Details

    Registration Name
    RMO
    Registration Number
    1718476
    FEI Number
    1718476
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2165 Earlywood Drive
    City
    Franklin
    State
    IN
    ZIP
    46131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030743

    Owner / Operator

    Firm Name
    RMO
    Operator Number
    10078580
    Address
    2165 Earlywood Drive
    City
    Franklin
    State
    IN
    Postal Code
    46131
    Country
    US
    Correspondent
    Brandon Bernacchi

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE
    Holder, Film, X-Ray EGZ
    Wax, Dental, Intraoral EGD
    Instrument, Ligature Tucking, Orthodontic ECP
    Band, Material, Orthodontic DYO
    Implant, Endosseous, Root-Form DZE
    Tray, Impression, Preformed EHY
    Accessories, Implant, Dental, Endosseous NDP
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Material, Tooth Shade, Resin EBF
    Driver, Band, Orthodontic ECT
    Material, Impression ELW
    Activator, Ultraviolet, For Polymerization EBZ
    Wire, Orthodontic DZC
    Maintainer, Space Preformed, Orthodontic DYT
    Protector, Dental BRW
    Plier, Orthodontic JEX
    Band, Elastic, Orthodontic ECI
    Retainer, Screw Expansion, Orthodontic DYJ
    Retractor, All Types EIG
    Mouthpiece, Saliva Ejector DYN
    Positioner, Tooth, Preformed KMY
    Applicator, Resin KXR
    Alloy, Other Noble Metal EJS
    Band, Preformed, Orthodontic ECM
    Tube, Orthodontic DZD
    Bracket, Ceramic, Orthodontic NJM
    Bracket, Metal, Orthodontic EJF
    Instruments, Dental Hand DZN
    Headgear, Extraoral, Orthodontic DZB
    Spring, Orthodontic ECO
    Bracket, Plastic, Orthodontic DYW
    Instrument, Cutting, Operative EKD
    Clasp, Preformed EHP
    Pusher, Band, Orthodontic ECS

    Proprietary Names

    TruLock Conditioner FITZGERALD X-RAY HOLDING UNIT Patient Relief Wax Schweickhardt/Apex Series Ligating pliers / ligature removal / ligature director/Tucker Truform Dual Top RMO Impression Tray Dual Top and Orthonia endosseous dental implant tools Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock Schweickhardt band adapter/SEATERS Ortho-Jel Alginate Flashmax P4 Light Curing Pen and Flashmax Accessories Bendaloy Titanium, Niti Coil Spring; Elgiloy; FLI Copper and FLI Aesthetic; Orthonol, Thermaloy Plus Thermaloy Nickel Titanium Wire; RMLocks, Hooks, Other Accessories; SWLRF Wires; TRU-CHROME Stainless Steel RMO Separators Space Maintainer, Lingual Arch, Bimetric Arch, Preformed Lingual Mouthguard Schweickhardt/Apex Series Pliers ELASTIC SEPARATORS; Elastic Thread; Elastics; Energy Chain; RMO ELASTOMERIC LIGATURES; Rotation Wedge Zero Corrector Rapid palatal expander Quad Helix, Multi-Action Appliance, Palatal Appliance, Adapter Cheek Retractor RMO Mouthgaurd Kussick Orthopedic Incline; Kussick Tongue Retrainer TruLock BRUSH and Sticks Bridging wire; Silver Solder Orthodontic Tubes Fli Clear M FLI mini;FLI Twin;Integra;Mini-Taurus;Alexander;Synergy;Synergy fx;Alpine SL;Mini Low Profile;Altitude SL;Mesh Base Bond Placement Tweezer / band and bracket removers; Cutters; Wire bending pliers Orthopedic Face Mask Elgiloy coil spring; Orthonol coil spring Alice Composite, Alice Composite Roth, Alice Composite Edgewise system Spring Gear/Safety Headgear; Facebow Penta-form; FLI CSL; Signature ceramic bracket Schweickhardt/Apex cutter Preformed wire clasp; RM Ball Retainer Clasp, Adams Clasp, J Clasp, Hawley Wire Schweickhardt Band Pusher

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility