BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHOFU DENTAL CORP.

    Reg #: 2916735 · FEI: 2916735 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    101
    Establishment Types
    1
    Classifications
    18

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    Registration Details

    Registration Name
    SHOFU DENTAL CORP.
    Registration Number
    2916735
    FEI Number
    2916735
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1225 Stone Dr
    City
    SAN MARCOS
    State
    CA
    ZIP
    92078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160203

    Owner / Operator

    Firm Name
    SHOFU INC.
    Operator Number
    9056340
    Address
    11 KAMITAKAMATSU-CHO, FUKUINE, HIGASHIYAMA-KU
    City
    KYOTO
    State
    JP-26
    Postal Code
    605-0983
    Country
    JP

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Agent, Tooth Bonding, Resin KLE
    Strip, Polishing Agent EHM
    Bur, Dental EJL
    Material, Tooth Shade, Resin EBF
    Cement, Dental EMA
    Mouthguard, Prescription MQC
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Disk, Abrasive EHJ
    Instruments, Dental Hand DZN
    Laser, Dental, Soft Tissue NVK
    Powered Laser Surgical Instrument GEX
    Intraoral Camera QJK
    Point, Abrasive EHL
    Applicator, Resin KXR
    Material, Impression Tray, Resin EBH
    Coating, Filling Material, Resin EBD

    Proprietary Names

    LAYZIR DISC BEAUTIBOND UNIVERSAL SUPER-SNAP POLYSTRIPS SUPER-SNAP IPR VINTAGE LD BEAUTIBOND XTREME THE ARTISTIC COMPOSITE KIT ROBOT CARBIDE BEAUTIBOND INCISAL EDGE WEAR KIT UNIVERSAL OPAQUE SHOFU ENAMEL CONDITIONER VINTAGE PRO BEAUTILINK SA DENTADISC BEAUTIFIL II LS SUPER-SNAP VINTAGE ART UNIVERSAL ZIRCONOMER P GLASIONOMER FX-LC MONOCEM BeautiSealant Needle Tips 23G MICD INSTRUMENTS BEAUTIFIL Needle Tips 18G BEAUTIFIL Needle Tips 20G-L BeautiSealant Needle Tips 27G BEAUTIFIL Needle Tips 20G DENTALAZE EYECAM GLASIONOMER FX ULTRA BEAUTIFIL II Enamel Beautifil II Gingiva PINK & Enamel WHITE Kit SHOFU MZ Primer Plus VINTAGE PRIME PRESS THE ATTACHMENT REMOVAL KIT FOR CLEAR ALIGNERS ZILMASTER BURBUTLER ALL CERAMIC ABRASIVE KIT BURBUTLER CADMASTER KIT DURAGREEN FINE ONE GLOSS ACRYPOINT DURAWHITE ACRYLIC KIT HP COREMASTER LAB CORAL DURA-GREEN FINE CERAMASTER DURA-GREEN STONES CERAMISTE AMALGAM & ALLOY POLISHING KIT CA LAB PINK SUPERGREENIE ZIRCONIA POLISHING KIT CA COMPOSITE POLISHING KIT CA DURAGREEN AMALGAM & ALLOY POLISHING KIT FG ACRYLIC POLISHING KIT HP COMPOSITE PORCELAIN & ENAMEL POLISHING KIT CA SUPERSNAP SUPERBUFF COMPOMASTER CERAMISTE SOFT GREENIE HARDIE COMPOSITE KIT CA ONE GLOSS PS SAMPLE PACK ZIRCONIA KIT CA LAB WHITE BROWNIE AMALGAM & METALS KIT CA PORCELAIN & ENAMEL KIT CA AMALGAM & METALS KIT FG SUPER SNAP X-TREME SAMPLE PACK AMALGAM & METALS POLISHING KIT FG DURA-WHITE STONES AMALGAM & METALS POLISHING KIT CA PINK PREPARATION BUT ACRYLIC POLISHING KIT SUPER-SNAP SUPERBUFF PORCELAIN BRUSH ART PORCELAIN BRUSH SET ART PORCELAIN BRUSH ART SET UNI BRUSH VINTAGE ART LF BEAUTICEM VENEER KIT DENTAPRINT TRINIA SHOFU RESIN GLAZE CERAMAGE UP UNIVERSAL OXYBARRIER BEAUTIFIL II Gingiva BEAUTIFIL II Gingiva PINK & Enamel WHITE Kit BEAUTIFIL II Gingiva Pink Kit HC PRIMER BEAUTIFIL FLOW PLUS X CLASS V PROCEDURE KIT CLEAR ALIGNER PROCEDURE KIT RESICEM EX FIT SA BEAUTIFIL KIDS SA

    Establishment Types

    Repack or Relabel Medical Device