Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009211643

FEI Number

3009211643

Entity Name

WEIHAI HUIHAI COMMODITY MANUFACTURE CO., LTD.

City/State/Country

Weihai Shandong, CN

Establishment Address

168 Huanhai Road, Huancui Zone, Weihai Shandong 264200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Weihai Huihai Commodity Manufacture Co., Ltd. (Owner Number: 10038407)

Owner / Operator Contact Address

168 Huanhai Road, Huancui Zone, Weihai, CN-SD 264200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stain remover ScalerPick LED Lighted Scaler with dentar Mirror Denture Box Dental Floss dental floss threader dental floss pick MIRROR, MOLITH Disposablerazor Back shaver

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2022-12-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2019-06-12
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2014-06-30
JES	Floss, Dental	Dental	Class 1	872.6390	2011-10-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-12-28
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-12-24

Official Correspondent

Junchao Sun

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Weihai Huihai Commodity Manufacture 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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3006186796	DENTSPLY NORTH AMERICA LLC	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009211643. Last updated year: 2026. Please use registration number 3009211643 when referencing this establishment in official correspondence.