Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042283835

FEI Number

3042283835

Entity Name

SHANWEI PERFECT MEDICAL INSTRUMENTS CO.,LTD.

City/State/Country

Shanwei Guangdong, CN

Establishment Address

No. 29, South side of Sanhe Road, West District, Hongcaoyuan District, High-tech Zone, Shanwei Guangdong 516600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanwei Perfect Medical Instruments Co.,Ltd. (Owner Number: 10094449)

Owner / Operator Contact Address

No. 29, South side of Sanhe Road, West District, Hongcaoyuan District, High-tech Zone, Shanwei, CN-GD 516600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gutta Percha Cutting Pen Dental Root-canal Instruments Gutta Percha Points Ultrasonic Irrigation Activator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2026-03-31
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-12-01
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-12-01
JET	Pick, Massaging	Dental	Class 1	872.6650	2026-03-31

Official Correspondent

Hansa Deng

US Agent Details

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

Related Public Records

Same Entity

Shanwei Perfect Medical 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Similar Registrations

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3016954909	IMPLANT PROTESIS DENTAL 2004, S.L.	Premia de Dalt Barcelona, ES
3005972890	GoldenDent	Roseville, MI, US
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042283835. Last updated year: 2026. Please use registration number 3042283835 when referencing this establishment in official correspondence.