Manufacturer registered with FDA
Guilin Woodpecker Medical Instrument Co., Ltd.
GUILIN, China. Lists 20 dental device types with FDA across 1 registered establishment, and holds 12 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 109
- 510(k) clearances
- 122006–2025
- Markets registered in
- 16587 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Guilin Woodpecker Medical Instrument Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd. | 12 clearances | 2006–2025 | Below |
| South Korea | MFDS | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd.Guilin Woodpecker Medical Instrument Co.,Ltd. · GUILIN WOODPECKER MEDICAL INSTRUMENT CO.,LTD. · +2 | 83 | 2005–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.GUILIN WOODPECKER MEDICAL INSTRUMENT CO. LTD. · GUILIN WOODPECKER MEDICAL INSTRUMENT CO.,LTD | 73 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guilin Woodpecker Medical Instrument Co Ltd | 71 | 2009–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.GUILIN WOODPECKER MEDICAL INSTRUMENT Co., Ltd. · GUILIN WOODPECKER MEDICAL INSTRUMENT CO., Ltd. | 68 | 2008–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD | 55 | 2013–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD | 49 | 2015–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd. | 33 | 2023–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd. | 30 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guilin Woodpecker Medical Instrument Co LtdGuilin Woodpecker Medical Instrument Co., Ltd. | 30 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd. | 25 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTDGUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD. | 24 | 2010–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Guilin Woodpecker Medical Instrument Co., Ltd.GUILIN WOODPECKER MEDICAL INSTRUMENT CO.,LTD. · Guilin Woodpecker Medical Instrument Co., Ltd · +1 | 22 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Guilin Woodpecker Medical Instrument Co., LtdGuilin Woodpecker Medical Instrument Co., Ltd. · GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD · +2 | 20 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Guilin Woodpecker Medical Instrument Co., LtdGuilin Woodpecker Medical Instrument Co., LTD | 3 | 2025–2025 | Pure Global AI |
| Japan | PMDA | Registration holder | ＧＵＩＬＩＮ ＷＯＯＤＰＥＣＫＥＲ ＭＥＤＩＣＡＬ ＩＮＳＴＲＵＭＥＮＴ ＣＯ．，ＬＴＤ | 1 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Guilin Woodpecker Medical Instrument Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Ai-surgery, Surgic smartDental Scaler and Air PolisherLove Hygiene AirPiezo Bone SurgeryPT-A PlusPT-A, AP-A, AP-BPT-BPT-B miniPT-E, PT-E PROSonus 14 moreSurgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LEDU6, U6 LED, S6, S6 LEDU600,U600 LED;D600,D600 LED;D6,D6 LED;UDS-N6,UDS-N6 LED, V6, V6 LEDUC500LUDS-A;UDS-P;UDS-E;UDS-P;UDS-E;D1;D3;D5;D7UDS-J;UDS-K;UDS-L;;UDS-N2UDS-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 LEDUDS-N3, V3,D7 LED;UDS-E LEDUDS-T LED, D8 LEDULTICLEAN UC600LUltrasonic Periodontal Treatment Device: PT 3,PT5Ultrasonic Scaler,Multiple ModelsUltrasurgeryUS-II, US-II LED,DS-II, DS-II LED | 2006 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TLContra-angle handpiece: WJ-45LContra-angle handpiece: WP-1, WP-1L, WJ-11LDental Electric MotorES5, ES5+, ES5 Pro, ES5 Pro+M2 ProMT2, MT3 | 2022 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Ai RayAi Ray Lite, Ai Ray Pro, Master RayDental X-Ray Device | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | ACECordless Prophy SystemE-COM, Endo RadarEndo Motor, Ai- Motor, Endo Radar PlusEndo Motor, CanalPro X-MoveEndo Motor, EDGEAPEX HPEndo Motor, Endo GT ProEndo Radar Pro, Endo SmartEndo SpaceEndoPro Ai1 6 morei-Polish; K-Po; Freestyle pro; promateCLMotopex, Endo Matic, Endo Smart+, E-Com+Prophy-MiniSmart A, Endo Pace, Endo Free, BAE380RUltrapro Tx Cordless812 MT | 2021 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Digital Intraoral X-Ray Imaging Systemi-Scan Imaging Plate Scanneri-Sensor H1; i-Sensor H2i-Sensor1.5Imaging Plate Scanner | 2021 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Ai-surgery, Surgic smartPiezo Bone SurgerySurgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LEDUltrasurgeryUS-II, US-II LED,DS-II, DS-II LED | 2011 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Tips of Ultrasonic Endo Activate | 2023 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental ExplorerSharpening Tool Bits | 2011 |
| Pulp TesterEAT · Class 2 | — | Maker | Ai-Pex | 2021 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | B-CureDental Curing Lighti LediLed IILED.B;LED.C,LED.DLED.E;LED.F;LED.H;LUX V, LUX ELED.GLUX VIMy-StarO-Light 5 moreO-Light IIO-StarV V LightX-CureX-Star | 2008 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AP-HAP-H PlusAP-MiniAP-Mini+AP-P, AP-P ProDental Air Polishing Handpiece | 2022 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TLContra-angle handpiece: WJ-45LDental Electric MotorES5, ES5+, ES5 Pro, ES5 Pro+M2 ProMT2, MT3 | 2022 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Dental Anesthesia Device (Model: Super Pen, Star Pen) | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Powder, Model: PT-S1, PT-S2, PT-S3 | 2020 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Gauge for Gutta-Percha-PointsR1, R1 Plus | 2023 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Root Canal (Endodontic) | 2023 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E | 2021 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Endo 1, Endo 3Ultrasonic Endo Activate Device | 2022 |
| AirbrushKOJ · Class 2 | — | Maker | Dental Scaler and Air PolisherLove Hygiene AirPT-A PlusPT-A, AP-A, AP-BPT-BPT-B miniPT-E, PT-E PROUC500LULTICLEAN UC600L | 2021 |
| Endodontic KitNYD · Class 2 | — | Maker | Terauchi File Removal Kit | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 2025 | K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | EHD Extraoral with Timer X-Ray Unit |
| 23 Nov 2022 | K222569 | Ai Ray Dental X-Ray Device | EHD Extraoral with Timer X-Ray Unit |
| 21 Nov 2022 | K211358 | Implanter incl. Accessories | EBW Handpiece and Cord Foot Controller |
| 28 Sep 2022 | K221548 | Dental Air Polishing Handpiece | EFB Dental Air-Powered Handpiece |
| 13 Jan 2022 | K203706 | Dental Electric Motor | EBW Handpiece and Cord Foot Controller |
| 17 Dec 2021 | K211531 | Cordless Prophy System, Model: i-Polish | EKX Ac-Powered Direct Drive Handpiece |
| 10 Dec 2021 | K203615 | Dental Scaler and Air Polisher | ELC Ultrasonic Scaler |
| 27 Sep 2021 | K212080 | Imaging Plate Scanner, i-Scan | MUH Digital Extraoral Source X-Ray System |
| 10 May 2021 | K203320 | Endo Motor | EKX Ac-Powered Direct Drive Handpiece |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | DZI Powered Bone Drill |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | EBZ Ultraviolet Activator for Polymerization |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Nordent MFG., Inc. (8), GoldenDent (7), Ads Dental System Inc. (5), Beyes Dental Inc (3), Prismatik Dentalcraft, Inc. (2), HSG-S Corp (2).
Also lists devices cleared under other names
Guilin Woodpecker Medical Instrument Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Iray Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTDFDA reg. 3005581016 | GUILIN CITY Guangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080879). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.