Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013526557

FEI Number

3013526557

Entity Name

SHOFU PRODUCTS KYOTO INC.

City/State/Country

Kyoto, JP

Establishment Address

21-1 Shintamaki, Ichida, Kumiyama-cho, Kuse-gun, Kyoto 613-0022, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

PRO ARCH HANDY IIM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJP	Articulators	Dental	Class 1	872.3150	1978-06-05

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
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
3002808149	SHOFU INC.	FUKUINE, HIGASHIYAMA-KU Kyoto, JP

Similar Registrations

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3011511773	Candulor Dental GmbH	Rielasingen-Worblingen Baden-Wurttemberg, DE
1043617	WHIP-MIX CORP.	LOUISVILLE, KY, US
3001297506	DARLEYS SURGICAL CO.	SIALKOT, PUNJAB, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013526557. Last updated year: 2026. Please use registration number 3013526557 when referencing this establishment in official correspondence.