BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PERMA LABORATORIES

    Reg #: 1528710 · FEI: 1000136230 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    PERMA LABORATORIES
    Registration Number
    1528710
    FEI Number
    1000136230
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    120 Wakefield Run Blvd
    City
    Hinckley
    State
    OH
    ZIP
    44233
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121318

    Owner / Operator

    Firm Name
    PERMA LABORATORIES
    Operator Number
    9006672
    Address
    120 Wakefield Run Blvd., --
    City
    Hinckley
    State
    OH
    Postal Code
    44233
    Country
    US
    Correspondent
    Melissa Lima

    Products

    Device Name Product Code
    Reliner, Denture, Over The Counter EBP
    Cleanser, Denture, Over The Counter EFT
    Denture Repair Kit EBO

    Proprietary Names

    Perma Soft Denture Reliner Fizz-It Denture Cleaner P.E.R.K. ProSoft Denture Reliner

    Establishment Types

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