BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioTemps NOW Milling Blocks; GD-Mandrel; A1 (5 units)

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PRISMATIK DENTALCRAFT, INC.
    Registration Number
    3011649314
    FEI Number
    3011649314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141421

    Owner / Operator

    Firm Name
    PRISMATIK DENTALCRAFT, INC.
    Operator Number
    10043585
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    Michelle Gallup

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    BioTemps NOW Milling Blocks; GD-Mandrel; A1 (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; B1 (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; A2 (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; BL (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; C2 (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; A3.5 (5 units) BioTemps NOW Milling Blocks; GD-Mandrel; A3 (5 units)

    Establishment Types

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