BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SHOFU INC.

    Reg #: 3002808149 · FEI: 3002808149 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    158
    Establishment Types
    3
    Classifications
    23

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    Registration Details

    Registration Name
    SHOFU INC.
    Registration Number
    3002808149
    FEI Number
    3002808149
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 KAMITAKAMATSU-CHO
    City
    FUKUINE, HIGASHIYAMA-KU Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K251470

    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
    Cement, Dental EMA
    Disk, Abrasive EHJ
    Instrument, Diamond, Dental DZP
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Powder, Porcelain EIH
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Strip, Polishing Agent EHM
    Condenser, Amalgam And Foil, Operative EKG
    Applicator, Resin KXR
    Handpiece, Air-Powered, Dental EFB
    Bur, Dental EJL
    Teeth, Porcelain ELL
    Coating, Filling Material, Resin EBD
    Instruments, Dental Hand DZN
    Carver, Dental Amalgam, Operative EKH
    Crown And Bridge, Temporary, Resin EBG
    Blender/Mixer JRO
    Denture, Plastic, Teeth ELM
    Varnish, Cavity LBH
    Sealant, Pit And Fissure, And Conditioner EBC
    Articulators EJP
    Point, Abrasive EHL

    Proprietary Names

    RESICEM EX SUPER-SNAP GlasIonomer Cement CX-Plus GLASIONOMER CEMENT CX-PLUS BEAUTIFIL BEAUTIFIL FLOW PLUS X CLASS V PROCEDURE KIT CLEAR ALIGNER PROCEDURE KIT FL BOND II BEAUTIFIL II LS VINTAGE LD IP TEMP CEMENT Ceraresin Bond P&R Repair Kit BEAUTIBOND UNIVERSAL BEAUTIFIL BULK FLOWABLE SHOFU COMPOSITE POLISHING PASTE COMPOSITE PASTE COMPOSITE POLISHING PASTE COMPOSITE PASTE GERMANY HY-BOND ZINC PHOSPHATE CEMENT RESICEM CEMENT AZ PRIMER PORCELAIN PRIMER SUPER-SNAP POLYSTRIPS SUPER-SNAP IPR BEAUTIFIL II Enamel Beautifil II Gingiva PINK & Enamel WHITE Kit VINTAGE ART LF LAYZIR DISC BEAUTIFIL BULK BEAUTIFIL E POSTERIOR Condenser VINTAGE MP PRESS OVER UNIVERSAL OPAQUE ZIRCONOMER P VINTAGE PRIME PRESS GLASIONOMER FX-II BEAUTICEM VENEER KIT PORCELAIN BRUSH ART PORCELAIN BRUSH SET ART PORCELAIN BRUSH ART SET UNI BRUSH GLASIONOMER FX-LC LAB AIR Z HANDPIECE HY-BOND POLY TEMP CEMENT VINTAGE MP VINTAGE GUMMY SHADE GUIDE Solidex SOLIDILITE V SOLIDILITE LED BEAUTIFIL FLOW VINTAGE HALO VINTAGE HALO MODEL LIQUID-L 500mL VINTAGE HALO OPAQUE LIQUID-L 50mL VINTAGE HALO MODEL LIQUID-L 50mL LITE ART SHOFU MZ Primer Plus BEAUTIFIL FLOW PLUS BEAUTILINK SA THE ARTISTIC COMPOSITE KIT ROBOT CARBIDE GLASIONOMER TYPE II CEMENT ANTI-GREENING LIQUID PORCELAIN STAIN POWDER BEAUTIFIL II SHOFU RESIN GLAZE FIT SA BEAUTIFIL KIDS SA BeautiSealant Needle Tips 23G MICD INSTRUMENTS BEAUTIFIL Needle Tips 18G BEAUTIFIL Needle Tips 20G-L BeautiSealant Needle Tips 27G BEAUTIFIL Needle Tips 20G CERAMAGE UP UNIVERSAL OXYBARRIER INSTRUMENT, DIAMOND, DENTAL GLASIONOMER BASE CEMENT VINTAGE LF SHOFU BLOCK HC SHOFU DISK HC BEAUTIBOND INCISAL EDGE WEAR KIT HY-BOND ZINC OXIDE TEMP CEMENT BEAUTIFIL OPAQUER HY-BOND RESIGLASS M.L. PRIMER VINTAGE AL VERACIA PRG BARRIER COAT VERACIA SA BEAUTISEALANT PRO ARCH HANDY IIM HY-BOND POLY CEMENT VINTAGE PRO CERAMAGE VINTAGE ART UNIVERSAL SHOFU ENAMEL CONDITIONER BEAUTIBOND XTREME 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 VINTAGE ZR VINTAGE ZR UNI-LAYER VINTAGE PORCELAIN VINTAGE PAINT OPAQUE LIQUID - 50mL BEAUTICEM SA VINTAGE ART HC PRIMER GLASIONOMER FX ULTRA BEAUTIFIL II Gingiva BEAUTIFIL II Gingiva PINK & Enamel WHITE Kit BEAUTIFIL II Gingiva Pink Kit

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device