BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTCA, INC.

    Reg #: 3009312537 · FEI: 3009312537 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    DENTCA, INC.
    Registration Number
    3009312537
    FEI Number
    3009312537
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17742 Cowan
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162044

    Owner / Operator

    Firm Name
    Dentca, Inc.
    Operator Number
    10039139
    Address
    17742 Cowan
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Jason Lee

    Products

    Device Name Product Code
    Tray, Impression, Preformed EHY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY

    Proprietary Names

    DENTCA Tray DENTCA Denture Base II/DENTCA Try-In DENTCA Design Pala Design Studio DENTCA Crown and Bridge DENTCA Base Hi-Impact DENTCA Base Premium DENTCA Denture Teeth

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility