BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Duo:PCH Cement

    Reg #: 2018957 · FEI: 2018957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DEN-MAT HOLDINGS, LLC
    Registration Number
    2018957
    FEI Number
    2018957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1017 W Central Ave
    City
    Lompoc
    State
    CA
    ZIP
    93436
    Country
    US

    Regulatory Submissions

    510(k) Number
    K881918

    Owner / Operator

    Firm Name
    DEN-MAT HOLDINGS, LLC
    Operator Number
    2018957
    Address
    1017 W. CENTRAL AVENUE, --
    City
    Lompoc
    State
    CA
    Postal Code
    93436
    Country
    US

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    Duo:PCH Cement Lumineers Placement Kit Holistore Ultra-Bond Clear Duo PCH Ultra-Bond Plus Geristore Block-Out Try-In Infinity SE Infinity GoldLink 2 Ultra-Bond Try-In Bio-Cap

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device