Guilin Woodpecker Medical Instrument Co., Ltd.
Manufacturer and brand owner in Guilin, Guangxi, China. 25 device types, 54 products catalogued, 14 clearances.
Guilin Woodpecker Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Airbrush, Tester, Pulp and 23 other device types. 48 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
25device types registered with the FDA
54products catalogued under its own name
14510(k) clearances
Registration
| Registered name | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005581016 |
| FEI number | 3005581016 |
| DUNS | 545272577 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 桂林市啄木鸟医疗器械有限公司 |
|---|---|
| Unified social credit code | 91450300715166426T |
| Source | NMPA UDI database |
Location
| City | Guilin |
|---|---|
| Province | Guangxi |
| Address | Information Industrial Park |
| Postal code | 541004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | Class 2 | Led.e;led.f;led.h;lux V, LUX E, LUX VI, i Led, O-Light, X-Cure, B-Cure and 9 more | 2008 | 7 |
| Agent, Polishing, Abrasive, Oral Cavity | Class 1 | Prophylaxis Powder, Model: PT-S1, PT-S2, PT-S3 | 2020 | 25 |
| Airbrush | Class 2 | Ulticlean UC600L, PT-A, AP-A, AP-B, Dental Scaler and Air Polisher, PT-B, UC500L, Love Hygiene Air and 3 more | 2021 | 1 |
| Controller, Foot, Handpiece And Cord | Class 1 | Contra-angle handpiece: WP-1, WP-1L, WJ-11L, Dental Implant Unit (Model: Implant-X, Implant-X LED, Implanter, Implanter LED, Implant NX, Implant Smart, Implant Air, Implant Pilot), Dental Electric Motor, MT2, MT3, ES5, ES5+, ES5 Pro, ES5 Pro+, Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL and 2 more | 2022 | 4 |
| Drill, Bone, Powered | Class 2 | 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 | 2011 | 2 |
| Endodontic Kit | Class 2 | Terauchi File Removal Kit | 2023 | 2 |
| Handpiece, Air-Powered, Dental | Class 1 | AP-H Plus, AP-P, AP-P Pro, Dental Air Polishing Handpiece, AP-H, AP-Mini+ | 2022 | 10 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | Dental Electric Motor, MT2, MT3, ES5, ES5+, ES5 Pro, ES5 Pro+, Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL, M2 Pro, Contra-angle handpiece: WJ-45L | 2022 | 9 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | i-Polish; K-Po; Freestyle pro; promateCL, Cordless Prophy System, Ultrapro Tx Cordless, Prophy-Mini, Endo Motor, Endo GT Pro, Smart A, Endo Pace, Endo Free, BAE380R and 10 more | 2021 | 10 |
| Instrument, Cutting, Operative | Class 1 | Gauge for Gutta-Percha-Points, R1, R1 Plus | 2023 | 5 |
| Instrument, Manual, Surgical, General Use | Class 1 | Endo File Remover | 2011 | 110 |
| Instruments, Dental Hand | Class 1 | Dental Explorer, Sharpening Tool Bits | 2011 | 64 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Dental Diode Laser System, D-Laser 16, D-Laser Blue, LX 16, LX16 Plus, Laser Smart, Laser Smart Blue | 2022 | 235 |
| Laser, Dental, Soft Tissue | Class 2 | Dental Diode Laser System, D-Laser 16, D-Laser Blue, LX 16, LX16 Plus, Laser Smart, Laser Smart Blue | 2022 | 5 |
| Locator, Root Apex | Class U | Apex Locator, Woodpex III, Woodpex V, Dpex V, Ai-Pex, Compex and 3 more | 2018 | 8 |
| Needle, Dental | Class 1 | Tips of Ultrasonic Endo Activate | 2023 | 56 |
| Pick, Massaging | Class 1 | Endo 1, Endo 3, Ultrasonic Endo Activate Device | 2022 | 46 |
| Plugger, Root Canal, Endodontic | Class 1 | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E | 2021 | 19 |
| Powered Laser Surgical Instrument | Class 2 | Dental Diode Laser System, D-Laser 16, D-Laser Blue, LX 16, LX16 Plus, Laser Smart, Laser Smart Blue | 2022 | 92 |
| Scaler, Ultrasonic | Class 2 | U600,U600 LED;D600,D600 LED;D6,D6 LED;UDS-N6,UDS-N6 LED, V6, V6 LED, Ultrasonic Periodontal Treatment Device: PT 3,PT5, Ultrasonic Scaler,Multiple Models, U6, U6 LED, S6, S6 LED, Sonus, UDS-A;UDS-P;UDS-E;UDS-P;UDS-E;D1;D3;D5;D7 and 18 more | 2006 | 14 |
| Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | Root Canal (Endodontic) | 2023 | 17 |
| Syringe, Cartridge | Class 2 | Dental Anesthesia Device (Model: Super Pen, Star Pen) | 2022 | 3 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | i-Scan Imaging Plate Scanner, Imaging Plate Scanner, i-Sensor H1; i-Sensor H2, Digital Intraoral X-Ray Imaging System, i-Sensor1.5 | 2021 | 10 |
| Tester, Pulp | Class 2 | Ai-Pex | 2021 | 2 |
| Unit, X-Ray, Extraoral With Timer | Class 2 | Dental X-Ray Device, Ai Ray, Ai Ray Lite, Ai Ray Pro, Master Ray | 2022 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Woodpecker | ELC | 501 |
| DTE | ELC | 113 |
| Dte,woodpecker | ELC | 40 |
| Woodpecker | EBZ | 37 |
| Woodpecker | DZI | 28 |
| DTE | EBZ | 17 |
| Woodpecker | EKX | 16 |
| DTE | EKX | 16 |
| Woodpecker,dte | ELC | 13 |
| DTE | EKR | 12 |
| Woodpecker | EKR | 12 |
| Dte,woodpecker | DZI | 11 |
| DTE | EBW | 11 |
| woodpecker | EBW | 10 |
| DTE | DZI | 6 |
| Woodpecker | EHD | 5 |
| DTE | MUH | 3 |
| DBA | ELC | 3 |
| Woodpecker | MUH | 3 |
| RTA | EBZ | 2 |
| Woodpecker | JET | 2 |
| Woodpecker | NVK | 2 |
| DTE | EGS | 2 |
| Woodpecker | EGS | 2 |
| DTE | NVK | 2 |
| Edegendo | EKR | 2 |
| DBA | MUH | 2 |
| DBA | EKR | 2 |
| DTE | EHD | 2 |
| Woodpecker,dte | EBZ | 2 |
| DTE | EFB | 2 |
| woodpecker | EFB | 2 |
| woodpecker | KOJ | 1 |
| Medidenta | EKX | 1 |
| DBA | EBZ | 1 |
| Dte,woodpecker | EKR | 1 |
| Dte,woodpecker | EGS | 1 |
| Love Hygiene | ELC | 1 |
| Woodpecker,dte | DZI | 1 |
| Edegendo | EKX | 1 |
| PacDent | EKX | 1 |
| Woodepcker | ELC | 1 |
| DBA | EGS | 1 |
| woodpecker | DZL | 1 |
| DTE | KOJ | 1 |
| Medidenta | ELC | 1 |
| DTE | JET | 1 |
| Woodpecker,dte | EBW | 1 |
Clearances
14 clearances name Guilin Woodpecker Medical Instrument Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251438 | 2025-09-04 | EHD | Special | This company |
| K222569 | 2022-11-23 | EHD | Traditional | This company |
| K211358 | 2022-11-21 | EBW | Traditional | This company |
| K221548 | 2022-09-28 | EFB | Traditional | This company |
| K210367 | 2022-03-10 | NVK | Traditional | This company |
| K203706 | 2022-01-13 | EBW | Traditional | This company |
| K211531 | 2021-12-17 | EKX | Traditional | This company |
| K203615 | 2021-12-10 | ELC | Traditional | This company |
| K212080 | 2021-09-27 | MUH | Traditional | This company |
| K203320 | 2021-05-10 | EKX | Traditional | This company |
| K181087 | 2018-12-18 | LQY | Traditional | This company |
| K111290 | 2011-11-18 | DZI | Traditional | This company |
| K080025 | 2008-03-19 | EBZ | Traditional | This company |
| K053555 | 2006-08-21 | ELC | Traditional | This company |
| K212279 | 2021-10-07 | MUH | Traditional | Iray Technology Taicang, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Dental equipment, Ultrasonic scalers, LED curing lights |
Nearby Manufacturers
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| Urit Medical Electronic Co., Ltd. | 28 |
| Guilin Yikeshi Medical Device Co Ltd | 28 |
| Guilin Kevin Peter Technology Co., Ltd. | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | 7 |
| Guilin Veirun Medical Technology Co., Ltd. | 4 |
| Guilin HBM Health Protections, Inc. | 2 |
| Guilin Huada Biotechnology Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.