BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Infinix Flowable Composite

    Reg #: 3015189878 · FEI: 3015189878 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NOBIO LTD.
    Registration Number
    3015189878
    FEI Number
    3015189878
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Hamatechet St.
    City
    Kadima Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K201010

    Owner / Operator

    Firm Name
    Nobio Ltd.
    Operator Number
    10079375
    Address
    8 Hamatechet
    City
    Kadima
    State
    Central
    Postal Code
    6092000
    Country
    IL
    Correspondent
    Maayan Mor

    US Agent

    Business Name
    ProMedoss, Inc.
    Contact Name
    Bosmat Friedman
    Address
    3521 Hatwynn Road
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    980 3081636

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    Infinix Flowable Composite Infinix Universal Composite Infinix Bulk Fill Flow Composite

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198