BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dharma Research/Medeco International

    Reg #: 3010131268 · FEI: 3010131268 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    52
    Establishment Types
    3
    Classifications
    11

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    Registration Details

    Registration Name
    Dharma Research/Medeco International
    Registration Number
    3010131268
    FEI Number
    3010131268
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5220 NW 72ND AVE STE 15
    City
    Miami
    State
    FL
    ZIP
    33166
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150696

    Owner / Operator

    Firm Name
    Dharma Research, Inc.
    Operator Number
    10043856
    Address
    5220 N.W. 72nd. Avenue, Unit #15
    City
    Miami
    State
    FL
    Postal Code
    33166
    Country
    US
    Correspondent
    Ricardo A Carles

    Products

    Device Name Product Code
    Zinc Oxide Eugenol EMB
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Agent, Tooth Bonding, Resin KLE
    Varnish, Cavity LBH
    Material, Impression ELW
    Tray, Fluoride, Disposable KMT
    Sealant, Pit And Fissure, And Conditioner EBC
    Material, Tooth Shade, Resin EBF
    Dam, Rubber EIE
    Paper, Articulation EFH

    Proprietary Names

    Dharma Eugenol ADS Eugenol Dharma Calcium Hydroxide ADS Zinc Oxide Sherbet Zinc Oxide Sherbet Calcium Hydroxide ADS Calcium Hydroxide Dharma Zinc Oxide Sherbet Eugenol Calix-CHG Chlorhexidine Irrigation Solution ADS Sodium Hypochlorite Solution Calix-E EDTA Irrigation Solution Calix Sodium Hypochlorite Solution Calix-X Enhanced Sodium Hypochlorite Solution ADS Chlorhexidine Irrigation Solution ADS EDTA Irrigation Solution Sherbet Chlorhexidine Irrigation Solution ADS Enhanced Sodium Hypochlorite Solution Sherbet EDTA Irrigation Solution Sherbet Enhanced Sodium Hypochlorite Solution Sherbet Sodium Hypochlorite Solution ADS Prophylaxis Paste Gelo-X Gel (Paste) Qartz Prophylaxis Paste Sherbet Prophylaxis Paste ADS Etchant Gels Jade Etchant Gels Sherbet Etchant Gels ADS Fluoride Varnish Citrine Fluoride Varnish Sherbet Fluoride Varnish Enthus Impression Material ADS Impression Material Sherbet Impression Material Ionite Fluoride Trays ADS Fluoride Trays Sherbet Fluoride Trays ADS Pit & Fissure Sealant Opaque Khameo Pit & Fissure Sealant Opaque Khameo Pit & Fissure Sealant Clear Sherbet Pit & Fissure Sealant Opaque ADS Pit & Fissure Sealant Clear Sherbet Pit & Fissure Sealant Clear Lapiss Hema Desensitizer ADS Hema Desensitizer Sherbet Hema Desensitizer Ehros Dental Dam Sherbet Dental Dam ADS Dental Dam Ehros Articulating Paper Sherbet Articulating Paper ADS Articulating Paper

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device