BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENGLE DENTAL SYSTEMS, LLC

    Reg #: 3020989 · FEI: 3020989 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ENGLE DENTAL SYSTEMS, LLC
    Registration Number
    3020989
    FEI Number
    3020989
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7205 NE Evergreen Pkwy Bldg E # 100
    City
    Hillsboro
    State
    OR
    ZIP
    97124
    Country
    US

    Regulatory Submissions

    510(k) Number
    K983285

    Owner / Operator

    Firm Name
    ENGLE DENTAL SYSTEMS, LLC
    Operator Number
    10047558
    Address
    7205 NE Evergreen PKWY, Bldg. B #100
    City
    Hillsboro
    State
    OR
    Postal Code
    97124
    Country
    US

    Products

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

    Proprietary Names

    E300 Chair E300 Wide E300 Narrow E300 Traverse E300 Traverse Narrow ENGLE 320 PACKAGE ENGLE 2200 PACKAGE ENGLE 310 PACKAGE ENGLE 360 PACKAGE WITH ENGLE 300 CHAIR WITH 360 LEFT/RIGHT DELIVERY ENGLE 1200 PACKAGE ENGLE 360 PACKAGE ENGLE 310 PACKAGE WITH ENGLE 300 CHAIR WITH 310 DELIVERY ENGLE 1200 PACKAGE WITH ENGLE 310 CHAIR, AND 1200 OR 2200 DELIVERY SYSTEM ENGLE 320 PACKAGE WITH ENGLE 300 CHAIR WITH 320 DELIVERY ENGLE DELIVERY CART ENGLE REAR DELIVERY ENGLE HYGIENE PACKAGE ENGLE SIDE DELIVERY ENGLE PANEL MOUNT DELIVERY ENGLE WALL MOUNTED DELIVERY E300 LED Ceiling Mounted Dental Light System E300 LED Post Mount Dental Light System

    Establishment Types

    Manufacture Medical Device