BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clearsplint ES

    Reg #: 1483306 · FEI: 1483306 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASTRON DENTAL CORPORATION
    Registration Number
    1483306
    FEI Number
    1483306
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    815 Oakwood Rd Ste G
    City
    Lake Zurich
    State
    IL
    ZIP
    60047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111828

    Owner / Operator

    Firm Name
    Astron Dental Corporation
    Operator Number
    1483306
    Address
    815 Oakwood Rd Unit G, --
    City
    Lake Zurich
    State
    IL
    Postal Code
    60047
    Country
    US
    Correspondent
    Beth Abbinanti

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC

    Proprietary Names

    Clearsplint ES Clearsplint Clearsplint Disc Ultraflex Labtec Pro Labtec Reline

    Establishment Types

    Repack or Relabel Medical Device