BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers

    Reg #: 2086043 · FEI: 3000719964 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PAC-DENT INC.
    Registration Number
    2086043
    FEI Number
    3000719964
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    670 Endeavor Circle
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151123

    Owner / Operator

    Firm Name
    Pac-Dent Inc.
    Operator Number
    10056434
    Address
    670 Endeavor Cir
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Tom Peng

    Products

    Device Name Product Code
    Dental Barriers And Sleeves PEM

    Proprietary Names

    Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers Air Techniques PSP Barrier Envelopes UNIVERSAL CURING LIGHT SHIELD Pac-Dent Barrier Sleeve, Cover It Barrier Film

    Establishment Types

    Repack or Relabel Medical Device