Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005581016

FEI Number

3005581016

Entity Name

GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD

City/State/Country

GUILIN CITY Guangxi, CN

Establishment Address

Information Industrial Park, Guilin National High-Tech Zone, GUILIN CITY Guangxi 541004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD (Owner Number: 9080879)

Owner / Operator Contact Address

Information Industrial Park, Guilin National High-Tech Zone, GUILIN, CN-GX 541004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203615

PMA Number

N/A

All Registered Proprietary Names

Ai Ray Lite, Ai Ray Pro, Master Ray Dental X-Ray Device Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E Endo Motor, Ai- Motor, Endo Radar Plus ACE Motopex, Endo Matic, Endo Smart+, E-Com+ Endo Radar Pro, Endo Smart Smart A, Endo Pace, Endo Free, BAE380R E-COM, Endo Radar Endo Motor, EDGEAPEX HP EndoPro Ai1 812 MT Endo Space Endo Motor, CanalPro X-Move Endo Motor, Endo GT Pro Dental Implant Unit (Model: Implant-X, Implant-X LED, Implanter, Implanter LED, Implant NX, Implant Smart, Implant Air, Implant Pilot) MT2, MT3 Dental Electric Motor ES5, ES5+, ES5 Pro, ES5 Pro+ M2 Pro Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL Root Canal (Endodontic) Dental Anesthesia Device (Model: Super Pen, Star Pen) Prophylaxis Powder, Model: PT-S1, PT-S2, PT-S3 Apex Locator Woodpex V Woodpex III DPEX V DPEX III Ai-Pex Minipex COMPEX Woodpex X, Dpex X Digital Intraoral X-Ray Imaging System i-Sensor H1; i-Sensor H2 i-Sensor1.5 US-II, US-II LED,DS-II, DS-II LED Surgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LED Piezo Bone Surgery Ai-surgery, Surgic smart Ultrasurgery Terauchi File Removal Kit Endo File Remover D-Laser 16, D-Laser Blue, LX 16, LX16 Plus Dental Diode Laser System Laser Smart, Laser Smart Blue Ultrasonic Endo Activate Device Endo 1, Endo 3 Gauge for Gutta-Percha-Points R1, R1 Plus U600,U600 LED;D600,D600 LED;D6,D6 LED;UDS-N6,UDS-N6 LED, V6, V6 LED Ultrasonic Periodontal Treatment Device: PT 3,PT5 U6, U6 LED, S6, S6 LED Ultrasonic Scaler,Multiple Models Sonus UDS-K LED;UDS-A LED;UDS-P LED;UDS-L LED;UDS-N3 LED;UDS-N2 LED;UDS-J2 LED;D3 LED;D5 LED;V3 LED;V2 LED UDS-A;UDS-P;UDS-E;UDS-P;UDS-E;D1;D3;D5;D7 UDS-T LED, D8 LED UDS-J;UDS-K;UDS-L;;UDS-N2 UDS-N3, V3,D7 LED;UDS-E LED Dental X-Ray Device Ai Ray i-Scan Imaging Plate Scanner Imaging Plate Scanner LED.E;LED.F;LED.H;LUX V, LUX E LUX VI i Led O-Light X-Cure B-Cure O-Star LED.G LED.B;LED.C,LED.D iLed II Dental Curing Light O-Light II V V Light X-Star My-Star Tips of Ultrasonic Endo Activate Ai-Pex AP-H Plus Dental Air Polishing Handpiece AP-P, AP-P Pro AP-Mini+ AP-Mini AP-H Dental Scaler and Air Polisher UC500L PT-A, AP-A, AP-B PT-B Love Hygiene Air Dental Electric Motor, PT-A Plus PT-B mini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2025-09-05
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-10-14
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2021-05-13
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-12-02
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2022-01-17
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-01-17
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2023-07-16
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2022-06-30
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2020-11-11
LQY	Locator, Root Apex	Unknown	Class U	N/A	2018-12-18
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-10-13
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2011-11-29
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2011-11-29
NYD	Endodontic Kit	Dental	Class 2	872.3820	2023-07-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-12-30
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-03-18
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2022-03-18
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-03-18
JET	Pick, Massaging	Dental	Class 1	872.6650	2022-03-18
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2023-01-10
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2006-02-06
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2022-11-26
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-09-27
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2008-03-25
DZM	Needle, Dental	Dental	Class 1	872.4730	2023-07-16
EAT	Tester, Pulp	Dental	Class 2	872.1720	2021-12-14
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2022-09-28
KOJ	Airbrush	Dental	Class 2	872.6080	2021-12-14
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2021-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

GUILIN WOODPECKER 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
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22

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.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005581016. Last updated year: 2026. Please use registration number 3005581016 when referencing this establishment in official correspondence.