Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006942526

FEI Number

3006942526

Entity Name

SHANGHAI SHOFU DENTAL MATERIAL CO. LTD

City/State/Country

Shanghai, CN

Establishment Address

No.645 Jiye Road, Sheshan Industrial Park, Songjiang, Shanghai 201602, CN

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

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 SUPER-SNAP AMALGAM & METALS POLISHING KIT CA PINK PREPARATION BUT ACRYLIC POLISHING KIT SUPER-SNAP SUPERBUFF THE ARTISTIC COMPOSITE KIT ROBOT CARBIDE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHL	Point, Abrasive	Dental	Class 1	872.6010	2003-10-06
EJL	Bur, Dental	Dental	Class 1	872.3240	1996-01-02

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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006942526. Last updated year: 2026. Please use registration number 3006942526 when referencing this establishment in official correspondence.