Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681750

FEI Number

3012356711

Entity Name

Bazhou City Xin an Town Hexin Medical Material Factory

City/State/Country

Hebei Province, CN

Establishment Address

Economic and Development Area, Toutun Village, Xin an Town, Bazhou, Hebei Province 065703, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Bazhou City Xin an Town Hexin Medical Material Factory (Owner Number: 9026919)

Owner / Operator Contact Address

Economic and Development Area, Touton Village, Xin an Town Baxian, HEBEI PROVINCE, CN-HE 065703, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Absorbent Paper Points

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1999-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: Dentsply Sirona Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

Bazhou City Xin an Town Hexin Medical Material Factory

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681750. Last updated year: 2026. Please use registration number 9681750 when referencing this establishment in official correspondence.