BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TEMREX CORP.

    Reg #: 2429849 · FEI: 2429849 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    16

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    Registration Details

    Registration Name
    TEMREX CORP.
    Registration Number
    2429849
    FEI Number
    2429849
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    300 Buffalo Ave
    City
    FREEPORT
    State
    NY
    ZIP
    11520
    Country
    US

    Regulatory Submissions

    510(k) Number
    K873686

    Owner / Operator

    Firm Name
    TEMREX CORP.
    Operator Number
    2429849
    Address
    300 BUFFALO AVE., P.O. BOX 182
    City
    Freeport
    State
    NY
    Postal Code
    11520
    Country
    US
    Correspondent
    ETHAN - LEVANDER

    Products

    Device Name Product Code
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Crown, Preformed ELZ
    Cement, Dental EMA
    Resin, Root Canal Filling KIF
    Paper, Articulation EFH
    Varnish, Cavity LBH
    Spectacle, Magnifying HOI
    Remover, Crown EIS
    Holder, Film, X-Ray EGZ
    Agent, Tooth Bonding, Resin KLE
    Instruments, Dental Hand DZN
    Material, Tooth Shade, Resin EBF
    Tray, Impression, Preformed EHY
    Eraser, Dental Stain MAU
    Catheter And Tip, Suction JOL
    Liner, Cavity, Calcium Hydroxide EJK

    Proprietary Names

    DIAMOND POLISHING PASTE Crown Forms ZINROC SATIN POLISHING PASTE INTERVAL DOC'S BEST RED / DOC'S BEST WHITE CANAL SEALER DOC'S BEST RED COPPER CEMENT POWDER: DOC'S BEST UNIVERSAL LIQUID ARTICULATING PAPER TEMREX CR COPALITE MAGNIFYING GLASSES MORELL CROWN REMOVER DOC'S BEST WHITE COPPER CEMENT POWDER BITE WING TABS SNAP BOND DENTIN ADHESIVE BITE WING LOOPS MATRIX BANDS INTERVAL LC Rite Bite Trays BITE RELATORS TEMREX CEMENT INTERVAL II PLUS GEL-ETCH GEL-WHITE / STAR WHITE TNE NON-EUGENOL CR PLUS ZOE PLUS PLAS-TIP ASPIRATING TIP / VAC-TIPS GENTLE-ETCH INTERFACE

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility