BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ortho Pro Dent LLC

    Reg #: 3013410675 · FEI: 3013410675 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    133
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    Ortho Pro Dent LLC
    Registration Number
    3013410675
    FEI Number
    3013410675
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1903 Northgate Blvd,Northogate Executive Center, suite 114
    City
    Sarasota
    State
    FL
    ZIP
    34234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012673

    Owner / Operator

    Firm Name
    Ortho Pro Dent LLC
    Operator Number
    10053964
    Address
    1903 Northgate Blvd , Northgate Executive center, suite 114
    City
    Sarasota
    State
    FL
    Postal Code
    34234
    Country
    US
    Correspondent
    EDWARD ELIAS

    Products

    Device Name Product Code
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Band, Preformed, Orthodontic ECM
    Plier, Orthodontic JEX
    Cement, Dental EMA
    Sealant, Pit And Fissure, And Conditioner EBC
    Preparer, Root Canal Endodontic EKQ
    Band, Elastic, Orthodontic ECI
    Crown, Preformed ELZ
    Bracket, Metal, Orthodontic EJF
    Wire, Orthodontic DZC
    Material, Tooth Shade, Resin EBF
    Dam, Rubber EIE
    Eraser, Dental Stain MAU
    Bracket, Ceramic, Orthodontic NJM
    Wax, Dental, Intraoral EGD
    Tube, Orthodontic DZD

    Proprietary Names

    Orthodontic adhesive light cure Orthodontic Adhesive - one step Mixing Adhesive bonding system Orthodontic adhesive Band cement acid etch and accessories Orthodontic Adhesive - No mix Devon Bond - light cure Max-Bond Orthodontic adhesive self bonding - light cure Max-Bond Adhesive light cure Devondent orthodontic Adhesive - light cure Orthodontic adhesive self bonding - light cure Devondent Orthodontic adhesive self bonding - light cure orthodontic band cleats orthodontic band and accessories ligual sheath promax bands Band Plain promax bands 1st Molar band , 2nd Molar band distal end cutter safety , distal end cutter long handle , dista end flush cutter angle plier, bird beak plier , three prong plier , jaraback plier , torquing plier male and female weingart plier , cinch back plier , Tweezer , bracket posioner , bracket holder , Tube holder Max Plier,Orthodontic Pliers , Dista end cutter , hard wire cutter , ligature pin cutters Dual Cure Luting Cement Zinc Phosphate Cement Light Cure Glass Ionomer Restorative Automix Dual Cure Luting Cement Zinc Oxide Eugenol Cement Non Eugenol Temporary Cement Polycarboxylate Cement Visible Light Cure Luting Surgical Cement Glass Ionomer Cement; Glass Ionomer Restorative Temporary Cement Zinc Oxide Eugenol Reinforced Material Visible Chemical Cure Pit and Fissure Visible Light Cure Pit and Fissure RC-CREAM Defon- Gel Root Canal Filling Material Orthodontic appliance and accessories ,elastomeric modules; Extraoral; Intraoral Ligature chain; Ligature ties; lip bumer tubing; Orthodontic elastomeric; rotation wedges; separators; thread Devon-Crown Trax-Plus Bracket Micro-Etched Roth slot 18 Trax-Plus Bracket Micro-Etched Roth slot 22 Self max-Selfligating Bracket System MBT slot 18 Trax-Plus Mini Twin Bracket MBT slot 18 Bracket accessories; Crimpabal hooks;Crimpabal stopers , lingual buttons; Metal bracket; Orthodontic brackets Trax-Plus Mini Twin Bracket Roth slot 22 Self max-Selfligating Bracket System Roth slot 18 Trax-Plus Mini Twin Bracket Roth slot 18 Self max-Selfligating Bracket System MBT slot 22 Trax-Plus Bracket Micro-Etched MBT slot 18 Trax-Plus Mini Twin Bracket MBT slot 22 Trax Bracket Micro-Etched Roth slot 18 Trax Bracket Micro-Etched Roth slot 22 Trax Bracket Micro-Etched MBT slot 18 Trax-Plus Bracket Micro-Etched MBT slot 22 Trax Bracket Micro-Etched MBT slot 22 Self max-Selfligating Bracket System Roth slot 22 alpha wire NiTi coated orthodontic wires alpha wire stainless steel wires coated TMA wires Orthodontic spring wires , Open coil , Closed coil alpha wire thermal activated wires alpha wire stainless steel wire alpha wire NiTi super elastic Orthodontic preformed ligature wires , Orthodontic Kobayshi wires Orthodontic stainless steel stranded wires Orthodontic reverse curved wires Devon-Core Devon-Core Dual Cure Core Automix Build Up Material DC Core Build Up Material Devon-Dent Chemical Core Build Up Material Devon-Dent Light Cure Core Build Up Material Core Build up material Devon- Gel Devon-Paste devonwhite in office bleaching system devonwhite bleaching , in office bleaching , devonwhite smile , Pro white smile, Pro white bleaching , dental bleaching Rannix - ceramic bracket with Metal slot system MBT slot 22 Translex - ceramic bracket system MBT slot 22 Translex - ceramic bracket system MBT slot 18 Orthodontic ceramic bracket. Glace- Crystal Sapphire Bracket System MBT slot 18 Orthodontic ceramic bracket with metal slot Rannix - ceramic bracket with Metal slot system MBT slot 18 Rannix - ceramic bracket with Metal slot system Roth slot 22 Glace- Crystal Sapphire Bracket System Roth slot 22 Rannix - ceramic bracket with Metal slot system Roth slot 18 Glace- Crystal Sapphire Bracket System MBT slot 22 Orthodontic Mono Crystalline Sapphire Bracket Glace- Crystal Sapphire Bracket System Roth slot 18 Translex - ceramic bracket system Roth slot 18 Translex - ceramic bracket system Roth slot 22 orthodontic wax Pressure Indicating Gel Visible Light Cure Flowable Composite Modeler Visible Light Cure Hybrid Composite Chemical Cure Dentin/Enamel Bonding Adhesive Separator Devon-Gel Etchant Gel Light Cure Dentin/Enamel Bonding Adhesive Light Cure One Step Dentin/Enamel Bonding Adhesive Hema Desensitizer Visible Light Cure Nano-Hybrid Composite Etchant Liquid Devon - Paste Porcelain Repair Kit Visible Light Cure Composite Restorative Material Porcelain Etchant Gel Devon-Dent Stains Primer Modifier Citric Acid Silane Bond Enhancer Self Etch Bonding Agent Surface Sealant Visible Light Cure Micro-Hybrid Composite Nano composite Chemical Cure Composite Restorative Material Porcelain Etchant Gel; Devon - Paste Porcelain Repair Kit; Self Etch Bonding Agent; Devon Dent Dual Cure Core Build Up ,Selfetch one-step bonding Chemical Cure Composite Restorative Material; Chemical Cure Dentin/Enamel Bonding Adhesive Silane Bond Enhancer; Surface Sealant; Visible Light Cure Composite Restorative Material Hema Desensitizer, Devon Dent Nano-Hybrid Composite refill Visible Light Cure Flowable Composite; Visible Light Cure Hybrid Composite Visible Light Cure Micro-Hybrid Composite; Visible Light Cure Nano-Hybrid Composite weldable buccal tube bondable buccal tube Trumpax buccal tube

    Establishment Types

    Repack or Relabel Medical Device