BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTONICS, INC.

    Reg #: 1721647 · FEI: 1721647 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    DENTONICS, INC.
    Registration Number
    1721647
    FEI Number
    1721647
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2833 TOPHILL RD.
    City
    MONROE
    State
    NC
    ZIP
    28110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121915

    Owner / Operator

    Firm Name
    DENTONICS, INC.
    Operator Number
    1721647
    Address
    2833 TOPHILL RD., --
    City
    Monroe
    State
    NC
    Postal Code
    28110
    Country
    US
    Correspondent
    RANDY - LEANDER

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Sealant, Pit And Fissure, And Conditioner EBC
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Tray, Impression, Preformed EHY
    Material, Impression ELW
    Resin, Root Canal Filling KIF
    Coating, Filling Material, Resin EBD
    Varnish, Cavity LBH
    Cement, Dental EMA
    Crown And Bridge, Temporary, Resin EBG
    Zinc Oxide Eugenol EMB

    Proprietary Names

    Material, Tooth Shade, Resin Master-Dent Root Canal Sealer Master-Dent Core Build-Up Material Master-Dent Anterior/Posterior Composite Restorative

    Establishment Types

    Repack or Relabel Medical Device