BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REKO DENTAL, LLC

    Reg #: 2087259 · FEI: 3003381355 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    34
    Establishment Types
    3
    Classifications
    19

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    Registration Details

    Registration Name
    REKO DENTAL, LLC
    Registration Number
    2087259
    FEI Number
    3003381355
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    17800 SOUTH MAIN, No. 201
    City
    GARDENA
    State
    CA
    ZIP
    90248
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131451

    Owner / Operator

    Firm Name
    MANUFACTURERA DENTAL CONTINENTAL
    Operator Number
    9032760
    Address
    2113 CALLE INDUST DEL PLASTICO, 269 FRACC ZAPOPAN INDUST NORTE
    City
    ZAPOPAN, JALISCO
    State
    MX-NOTA
    Postal Code
    45210
    Country
    MX

    Products

    Device Name Product Code
    Cleanser, Denture, Over The Counter EFT
    Wax, Dental, Intraoral EGD
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Light, Operating, Dental EAZ
    Teeth, Artificial, Backing And Facing ELK
    Reliner, Denture, Over The Counter EBP
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium KOT
    Material, Impression ELW
    Frame, Rubber Dam EJE
    Crown And Bridge, Temporary, Resin EBG
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Dam, Rubber EIE
    Alloy, Metal, Base EJH
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Articulators EJP
    Eraser, Dental Stain MAU

    Proprietary Names

    Confident Denture Cleaner Calibrated Wax Rogson Wax Polycril MDC DENTAL OPERATING LIGHT ISOTEK TEETH NEW TEK TEETH Edge Liner Paltop Dental Sterile Accessories Confident Denture Adhesive Powder Confident Denture Adhesive Cream Paltop Dynamic C Dental Implant System Novel Print Cyan Alginates EDGE Condensation Max Print Cromatico Max Print PVS Edge Bio-Jel Max Print Cyan MDC NIC TONE RUBBER DAM Nic Tone Acrylic Resins Nic Tone PolyCril Nic Tone Selfcure Liquid Bisacryl NicTone Nic Tone Synthetic Dam Ready Dam NIC TONE RUBBER DAM Mesa Alloys i500: MD-ID300 Dental Scanner Medit i700 Dental Scanner Medit i700 Wireless Dental Scanner Paltop Narrow Implant, Paltop PCA Dental Implant system MDC Dental Articulator AntiVet Whitening Kit

    Establishment Types

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