BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reflect

    Reg #: 3010730876 · FEI: 3010730876 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Biotech Dental
    Registration Number
    3010730876
    FEI Number
    3010730876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    145 Cedar Lane, Suite 205
    City
    Englewood
    State
    NJ
    ZIP
    07631
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180924

    Owner / Operator

    Firm Name
    Biotech Dental
    Operator Number
    10083785
    Address
    145 Cedar Lane, Suite 205
    City
    Englewood
    State
    NJ
    Postal Code
    07631
    Country
    US
    Correspondent
    David Singh

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Reflect

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198