BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SunClear Aligner

    Reg #: 3006430881 · FEI: 3006430881 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SUN DENTAL LABORATORIES LLC
    Registration Number
    3006430881
    FEI Number
    3006430881
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 9th Ave N
    City
    Saint Petersburg
    State
    FL
    ZIP
    33713
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190394

    Owner / Operator

    Firm Name
    SUN DENTAL LABORATORIES LLC
    Operator Number
    9065239
    Address
    1800 9th Ave N
    City
    Saint Petersburg
    State
    FL
    Postal Code
    33713
    Country
    US
    Correspondent
    DEREK - DIASTI

    Products

    Device Name Product Code
    Bracket, Plastic, Orthodontic DYW
    Aligner, Sequential NXC

    Proprietary Names

    SunClear Aligner

    Establishment Types

    Manufacture Medical Device