Medical Device Manufacturer · US , Flintville , TN

Guilin Woodpecker Medical Instrument Co., Ltd.

14 submissions · 14 cleared · Since 2006
14
Total
14
Cleared
0
Denied

Guilin Woodpecker Medical Instrument Co., Ltd. — FDA 510(k) Submissions

Guilin Woodpecker Medical Instrument Co., Ltd. has submitted 14 FDA 510(k) premarket notifications since 2006, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Scaler, Ultrasonic, Handpiece, Direct Drive, Ac-powered, Controller, Foot, Handpiece And Cord, Unit, X-ray, Extraoral With Timer, Activator, Ultraviolet, For Polymerization . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · EHD Unit, X-ray, Extraoral... · Radiology
Sep 2025 118d
Ai Ray Dental X-Ray Device
K222569 · EHD Unit, X-ray, Extraoral... · Radiology
Nov 2022 91d
Implanter incl. Accessories
K211358 · EBW Controller, Foot,... · Dental
Nov 2022 567d
Dental Air Polishing Handpiece
K221548 · EFB Handpiece, Air-powered,... · Dental
Sep 2022 124d
D-Laser Blue, D-Laser 16
K210367 · NVK Laser, Dental, Soft Tissue · Dental
Mar 2022 395d
Dental Electric Motor
K203706 · EBW Controller, Foot,... · Dental
Jan 2022 391d
Cordless Prophy System, Model: i-Polish
K211531 · EKX Handpiece, Direct Drive,... · Dental
Dec 2021 214d
Dental Scaler and Air Polisher
K203615 · ELC Scaler, Ultrasonic · Dental
Dec 2021 365d
Imaging Plate Scanner, i-Scan
K212080 · MUH System, X-ray, Extraoral... · Radiology
Sep 2021 87d
Endo Motor
K203320 · EKX Handpiece, Direct Drive,... · Dental
May 2021 179d
Apex Locator, DPEX III
K181087 · LQY Locator, Root Apex · Dental
Dec 2018 237d
PIEZO BONE SURGERY
K111290 · DZI Drill, Bone, Powered · Dental
Nov 2011 196d
LED.L, LED.M, LED.G, LED.B
K080025 · EBZ Activator, Ultraviolet,... · Dental
Mar 2008 75d
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
K053555 · ELC Scaler, Ultrasonic · Dental
Aug 2006 244d
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