BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oral Biotech LLC

    Reg #: 3005686375 · FEI: 3003422682 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    Oral Biotech LLC
    Registration Number
    3005686375
    FEI Number
    3003422682
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    812 Water Ave Ne
    City
    ALBANY
    State
    OR
    ZIP
    97321
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153334

    Owner / Operator

    Firm Name
    Oral Biotech
    Operator Number
    9085004
    Address
    812 Water AVE NE
    City
    Albany
    State
    OR
    Postal Code
    97321
    Country
    US
    Correspondent
    John Bowers

    Products

    Device Name Product Code
    Floss, Dental JES
    Toothbrush, Manual EFW
    Culture Media, Non-Selective And Differential JSH
    Varnish, Cavity LBH

    Proprietary Names

    CariFree Mineral Enhanced Floss Carifree Toothbrush CARISCREEN ATP BACTERIAL TEST CariFree Fluoride Varnish

    Establishment Types

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