BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JENSEN INDUSTRIES, INC.

    Reg #: 1219645 · FEI: 1219645 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    67
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    JENSEN INDUSTRIES, INC.
    Registration Number
    1219645
    FEI Number
    1219645
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    50 STILLMAN RD.
    City
    NORTH HAVEN
    State
    CT
    ZIP
    06473
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011394

    Owner / Operator

    Firm Name
    JENSEN INDUSTRIES, INC.
    Operator Number
    1219645
    Address
    50 STILLMAN RD., --
    City
    North Haven
    State
    CT
    Postal Code
    06473
    Country
    US

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Alloy, Other Noble Metal EJS
    Alloy, Gold-Based Noble Metal EJT
    Articulators EJP
    Teeth, Porcelain ELL
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    LAVA Frame MiYO Esthetic System MiYO Pink InSync Ceramic System MiYO 850 Lava Esthetic JWE Select J-7 Superior Pulse N3 Platinum Foil 0008 Castell JWG Landmark ECO Platinum Foil 001 1400 Solder Stability Security Blaze JP-5 Superior Plus Advantage Integrity State Solution JP-5 w/ Au 650 Solder JCBD Sentry JYE Aztec SL-40 JPW Classic IV Spirt Solder J-3 JP-I JMC Gold Foil JLCB JP-80 Equity JIV-PF JP-1-A JIV CPS Solder Verity JRVT-PF JP-II LX Solder Galileo JA Overture Foundation J-22 JRVT 585 Solder JC P-80 Solder Endurance 615 Solder JCB PWS Solder Artex MiYO Enamel Effect Liquid Imagine Enamel Liquid

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device