SHOFU INC.

FDA Device Registration & Listing · FUKUINE, HIGASHIYAMA-KU Kyoto, JP · Registration 3002808149

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002808149
FEI Number
3002808149
Entity Name
SHOFU INC.
City/State/Country
FUKUINE, HIGASHIYAMA-KU Kyoto, JP
Establishment Address
11 KAMITAKAMATSU-CHO, FUKUINE, HIGASHIYAMA-KU Kyoto 605-0983, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SHOFU INC. (Owner Number: 9056340)
Owner / Operator Contact Address
11 KAMITAKAMATSU-CHO, FUKUINE, HIGASHIYAMA-KU, KYOTO, JP-26 605-0983, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K841196
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMA Cement, Dental Dental Class 2 872.3275 2025-12-18
EHJ Disk, Abrasive Dental Class 1 872.6010 1978-06-05
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 1978-06-05
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2018-01-17
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-06-10
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-02-03
EIH Powder, Porcelain Dental Class 2 872.6660 2016-01-15
EMA Cement, Dental Dental Class 2 872.3275 2011-11-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2012-12-03
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2018-12-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-10-25
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2007-05-29
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
EMA Cement, Dental Dental Class 2 872.3275 2008-06-12
EHM Strip, Polishing Agent Dental Class 1 872.6010 2021-12-02
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2016-01-11
EIH Powder, Porcelain Dental Class 2 872.6660 2016-01-15
EIH Powder, Porcelain Dental Class 2 872.6660 2024-09-23
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-12-17
EKG Condenser, Amalgam And Foil, Operative Dental Class 1 872.4565 2003-10-06
EIH Powder, Porcelain Dental Class 2 872.6660 2013-05-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-02-05
EMA Cement, Dental Dental Class 2 872.3275 2026-01-27
EIH Powder, Porcelain Dental Class 2 872.6660 2024-04-02
EMA Cement, Dental Dental Class 2 872.3275 2013-01-08
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-06-13
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-06-13
KXR Applicator, Resin Dental Class 1 872.3140 2022-09-26
EMA Cement, Dental Dental Class 2 872.3275 2026-01-27
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2008-06-11
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
EIH Powder, Porcelain Dental Class 2 872.6660 2010-04-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-06-09
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-06-10
EIH Powder, Porcelain Dental Class 2 872.6660 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-08-25
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2017-09-11
EMA Cement, Dental Dental Class 2 872.3275 2017-09-11
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-08-25
EMA Cement, Dental Dental Class 2 872.3275 2023-10-17
EJL Bur, Dental Dental Class 1 872.3240 1996-01-02
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
ELL Teeth, Porcelain Dental Class 2 872.3920 2008-06-10
EIH Powder, Porcelain Dental Class 2 872.6660 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-06-10
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2017-08-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-08-28
DZN Instruments, Dental Hand Dental Class 1 872.4565 2015-11-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-01-11
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 2003-10-06
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10
EIH Powder, Porcelain Dental Class 2 872.6660 2008-06-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-10-25
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-10-25
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-12-18
EMA Cement, Dental Dental Class 2 872.3275 2008-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Mike Gainsburg Email: mgainsburg@shofu.com Phone: (800) 8274638

Related Public Records

Same Entity

SHOFU INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013526557 SHOFU PRODUCTS KYOTO INC. Kyoto, JP
3006942526 SHANGHAI SHOFU DENTAL MATERIAL CO. LTD Shanghai, CN
3011814610 SHIGA SHOFU INC. Koka Shiga, JP
3031601673 SHOFU PRODUCTS VIETNAM CO., LTD Dong Van Ward Ninh Binh, VN
2916735 SHOFU DENTAL CORP. SAN MARCOS, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09
K940030 Bisco, Inc. BISCO COMPOSITE 1994-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808149. Last updated year: 2026. Please use registration number 3002808149 when referencing this establishment in official correspondence.
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