Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009431661

FEI Number

3009431661

Entity Name

SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 103, Building 3, No. 2, Weiqun Road, 4th Community, Henggang Street, Longgang District, Shenzhen Guangdong 518115, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Perfect Medical Instruments Co., Ltd. (Owner Number: 10041190)

Owner / Operator Contact Address

Room 103, Building 3, No. 2, Weiqun Road, 4th Community, Henggang Street, Longgang District, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FILE, PULP CANAL, ENDODONTIC; profa file Gutta Percha Points, Injectable Root Canal Sealer Absorbent Paper Points Endo Motor Irrigation Needle BUR, DENTAL; profa dental bur WIRE, ORTHODONTIC; profa wires

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2012-06-28
EKM	Gutta-Percha	Dental	Class 1	872.3850	2023-10-19
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-10-19
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-05-06
LQY	Locator, Root Apex	Unknown	Class U	N/A	2023-05-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2024-06-25
EJL	Bur, Dental	Dental	Class 1	872.3240	2012-06-28
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2012-06-28

Official Correspondent

Abby Woo

US Agent Details

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

Related Public Records

Same Entity

Shenzhen 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
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3042158426	INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI	Istanbul, TR
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009431661. Last updated year: 2026. Please use registration number 3009431661 when referencing this establishment in official correspondence.