Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011169597

FEI Number

3011169597

Entity Name

Dacheng Huaguan Dental Instruments Co., Ltd

City/State/Country

Langfang Hebei, CN

Establishment Address

North East of Zusi Industrial Zone, Dacheng County, Langfang Hebei 065900, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Dacheng Huaguan Dental Instruments Co., Ltd. (Owner Number: 10045372)

Owner / Operator Contact Address

North East of Zusi Industrial Zone, Dacheng County, Langfang, CN-HE 065900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bite Tray impression tray Plastic Holder Plastic Traps Plastic Tubes Saliva Ejector Mouthpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2013-11-10
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2014-01-09
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2013-11-10

Official Correspondent

Marina Bi

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Dacheng Huaguan Dental Instruments 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

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3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011169597. Last updated year: 2026. Please use registration number 3011169597 when referencing this establishment in official correspondence.