Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011814610

FEI Number

3011814610

Entity Name

SHIGA SHOFU INC.

City/State/Country

Koka Shiga, JP

Establishment Address

2296 Kinose, Shigaraki-cho,, Koka Shiga 529-1802, 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

Expiration Date (Year)

2026

510(k) Number

K200470

PMA Number

N/A

All Registered Proprietary Names

VERACIA SA SHOFU BLOCK HC SHOFU DISK HC VERACIA SHOFU BLOCK HC HARD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2012-02-24
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
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2015-06-23
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-02-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-02-11

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
3031601673	SHOFU PRODUCTS VIETNAM CO., LTD	Dong Van Ward Ninh Binh, VN
2916735	SHOFU DENTAL CORP.	SAN MARCOS, CA, US
3002808149	SHOFU INC.	FUKUINE, HIGASHIYAMA-KU Kyoto, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

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.).

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011814610. Last updated year: 2026. Please use registration number 3011814610 when referencing this establishment in official correspondence.