BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AKERVALL TECHNOLOGIES

    Reg #: 3011547262 · FEI: 3011547262 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    5
    Classifications
    5

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    Registration Details

    Registration Name
    AKERVALL TECHNOLOGIES
    Registration Number
    3011547262
    FEI Number
    3011547262
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1512 Woodland Dr
    City
    Saline
    State
    MI
    ZIP
    48176
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121272

    Owner / Operator

    Firm Name
    Akervall Technologies Inc.
    Operator Number
    10048970
    Address
    1512 Woodland Dr.
    City
    Saline
    State
    MI
    Postal Code
    48176
    Country
    US

    Products

    Device Name Product Code
    Splint, Hand, And Components ILH
    Mouthguard, Over-The-Counter OBR
    Cleanser, Denture, Over The Counter EFT
    Tray, Impression, Preformed EHY
    Protector, Dental BRW

    Proprietary Names

    SOVA Night Guard SOVA MAX SOVA Junior SOVA Aero Intuguard

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility