Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000303964

FEI Number

3000303964

Entity Name

DENTSPLY DENTAL (TIANJIN) CO., LTD.

City/State/Country

TEDA Tianjin, CN

Establishment Address

H2 Hongtai Industrial Estate No. 78, Taihua Road, TEDA Tianjin 300457, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DENTSPLY SIRONA INC (Owner Number: 2511302)

Owner / Operator Contact Address

221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	1992-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA 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
9612618	DEGUDENT GMBH	Rosbach V.D.H. Hesse, DE
3003756493	DENTSPLY INDUSTRIA E COMERCIO LTDA	PIRASSUNUNGA Sao Paulo, BR
3001226627	RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)	ST. EGREVE Isere, FR
3003136642	OraMetrix GmbH	Berlin Brandenburg, DE
9611053	VDW GMBH	MUNICH Bavaria, DE

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000303964. Last updated year: 2026. Please use registration number 3000303964 when referencing this establishment in official correspondence.