Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016075921

FEI Number

3016075921

Entity Name

GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Guilin Guangxi, CN

Establishment Address

NO.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin Guangxi 541004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guilin Refine Medical Instrument Co., LTD. (Owner Number: 10064688)

Owner / Operator Contact Address

No. 8-3, Information Industrial Park High-Tech Zone, Qixing District, Guilin, CN-GX 541004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223414

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Activator (Model: VAT-3) External Oral Aerosol Suction System Portable Dental X-ray Device (Model: GT-1) Curing Light (Model: MaxCure9)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-01-05
JET	Pick, Massaging	Dental	Class 1	872.6650	2023-11-19
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2020-10-24
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2026-04-21
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-11-19

Official Correspondent

Rong Wen

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Guilin Refine Medical Instrument 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
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3042256012	QUANZHOU AGURU E-COMMERCE CO., LTD	Quanzhou Fujian, CN
1052939	Medidenta	Las Vegas, NV, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3003933619	MECTRON S.P.A.	CARASCO Genova, IT
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016075921. Last updated year: 2026. Please use registration number 3016075921 when referencing this establishment in official correspondence.