BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTALEZ OF ALABAMA

    Reg #: 1049061 · FEI: 1049061 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    DENTALEZ OF ALABAMA
    Registration Number
    1049061
    FEI Number
    1049061
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2500 U.S. HIGHWAY 31 SOUTH
    City
    BAY MINETTE
    State
    AL
    ZIP
    36507
    Country
    US

    Regulatory Submissions

    510(k) Number
    K931204

    Owner / Operator

    Firm Name
    DENTALEZ, INC.
    Operator Number
    2513147
    Address
    301 Lindenwood Drive, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Chair, Dental, Without Operative Unit NRU
    Light, Operating, Dental EAZ
    Unit, Operative Dental EIA
    Unit, Operative Dental, Accessories NRD

    Proprietary Names

    NuSimplicity Chair CORE Chair CORE Light Simplicity Light Simplicity LED Light CORE Delivery Unit Galaxy Delivery Unit Ramvac 3 Compressor Ramvac Tanks 30 Gallon Tank Ramvac 7 Dry Vacuum System (Bison 5) Ramvac 12 Dry Vacuum System (Bison 9) Ramvac 5 Dry Vacuum System (Bison 3) Ramvac 4 Dry Vacuum System (Bulldog QT 2) Barracuda MC-202 Ramvac 12 Compressor Ramvac Tanks 15 Gallon Tank Ramvac 5 Compressor Ramvac Tanks Infini Tank Ramvac 18 Compressor Ramvac 5 Compressor w/Sound Shield NXT Hg5 Amalgam Separator Barracuda MC-201 Ramvac Badger LF Dry Vacuum Ramvac 10 Dry Vacuum System (Bison 7) Ramvac 8 Compressor NXT Hg5 High Volume Amalgam Separator Ramvac Tanks 50 Gallon Cylindrical Tank Barracuda CV-102 Ramvac 3 Compressor w/Sound Shield NXT Hg5 MINI Amalagam Separator Barracuda CV-101

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198