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Data / Medical devices / China / Guilin Woodpecker Medical Instrument Co., Ltd

Guilin Woodpecker Medical Instrument Co., Ltd: FDA-registered device maker in GUILIN CITY Guangxi, China, 15 510(k) clearances

Guilin Woodpecker Medical Instrument Co., Ltd is registered with the FDA (registration 3005581016) in GUILIN CITY Guangxi, China. It lists 25 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 4, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Guilin Woodpecker Medical Instrument Co., Ltd
FDA registration number
3005581016
Address
Information Industrial Park Guilin National High-Tech Zone, GUILIN CITY Guangxi, China, 541004
Owner or operator
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD (9080879)
Roles
Manufacturer
First device listed
February 6, 2006
Registered through
2026
Brand names listed
812 MT, ACE, AP-H, AP-H Plus, AP-Mini, AP-Mini+, AP-P, AP-P Pro, Ai Ray and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
AirbrushKOJ2Manufactureraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Manufactureraccessdata.fda.gov
Drill, Bone, PoweredDZI2Manufactureraccessdata.fda.gov
Endodontic KitNYD2Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Manufactureraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Manufactureraccessdata.fda.gov
Locator, Root ApexLQYUManufactureraccessdata.fda.gov
Needle, DentalDZM1Manufactureraccessdata.fda.gov
Pick, MassagingJET1Manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Manufactureraccessdata.fda.gov
Syringe, CartridgeEJI2Manufactureraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Manufactureraccessdata.fda.gov
Tester, PulpEAT2Manufactureraccessdata.fda.gov
Unit, X-Ray, Extraoral With TimerEHD2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 4, 2025K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHDSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
November 23, 2022K222569Ai Ray Dental X-Ray DeviceEHDSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
November 21, 2022K211358Implanter incl. AccessoriesEBWSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
September 28, 2022K221548Dental Air Polishing HandpieceEFBSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
March 10, 2022K210367D-Laser Blue, D-Laser 16NVKSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
January 13, 2022K203706Dental Electric MotorEBWSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 17, 2021K211531Cordless Prophy System, Model: i-PolishEKXSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 10, 2021K203615Dental Scaler and Air PolisherELCSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
October 7, 2021K212279Digital Intraoral X-ray Imaging SystemMUHSubstantially EquivalentIray Technology Taicang , Ltd.accessdata.fda.gov
September 27, 2021K212080Imaging Plate Scanner, i-ScanMUHSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
May 10, 2021K203320Endo MotorEKXSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 18, 2018K181087Apex Locator, DPEX IIILQYSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
November 18, 2011K111290PIEZO BONE SURGERYDZISubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
March 19, 2008K080025LED.L, LED.M, LED.G, LED.BEBZSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
August 21, 2006K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LELCSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.