Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015542306

FEI Number

3015542306

Entity Name

CHANGSHU SHANGCHI DENTAL MATERIALS CO., LTD.

City/State/Country

Changshu Jiangsu, CN

Establishment Address

No.15 Zhibei Zhongxin Road Changgiao Village, Zhitang Town. Changshu/Jiangsu,P.R.China, Changshu Jiangsu 215531, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ChangShu ShangChi Dental Materials Co., Ltd. (Owner Number: 10090946)

Owner / Operator Contact Address

No.15 Zhibei Zhongxin Road Changgiao Village, Zhitang Town. Changshu/Jiangsu,P.R.China, Changshu, CN-JS 215531, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENTAL WAX Dental Alloy Series Zinc Oxide Eugenol Cement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2025-03-20
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2024-06-05
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2025-09-24

Official Correspondent

Zumin Du

US Agent Details

ANNA SUN Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

ChangShu ShangChi Dental Materials Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015542306. Last updated year: 2026. Please use registration number 3015542306 when referencing this establishment in official correspondence.