# Guilin Woodpecker Medical Instrument Co., Ltd.

- Location (FDA's records): Guilin, CN
- FDA decisions: 14 (2006–2025): 14 510(k) clearances
- Product codes: EBW (2), ELC (2), EHD (2), EKX (2), MUH (1), EFB (1), EBZ (1), LQY (1), NVK (1), DZI (1)
- 510(k) review time since 2016: median 214 days, against 214 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- E.M.S Electro Medical Systems S.A: 2 (https://510kreport.com/company/ems-electro-medical-systems-s-a)
- Dentsply Sirona: 2 (https://510kreport.com/company/dentsply-sirona)
- Duerr Dental AG: 1 (https://510kreport.com/company/duerr-dental)
- W&H Dentalwerk Bürmoos GmbH: 1 (https://510kreport.com/company/w-h-dentalwerk-burmoos)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Nakanishi, Inc.: 1 (https://510kreport.com/company/nakanishi)
- Young Dental Manufacturing Co. 1, LLC: 1 (https://510kreport.com/company/young-dental-manufacturing-co-1)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)

## Firms that cite its devices most
- Cefla S.C.: 1 (https://510kreport.com/company/cefla-sc)
- Jiangsu Dynamic Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-dynamic-medical-technology)
- Shenzhen Rogin Medical Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-rogin-medical)
- Changzhou Sifary Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/changzhou-sifary-medical-technology)
- Foshan Coxo Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/foshan-coxo-medical-instrument)
- Gigaalaser Company, Ltd.: 1 (https://510kreport.com/company/gigaalaser)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd: 1 (https://510kreport.com/company/shanghai-wonderful-opto-electrics-tech)
- Nanning Baolai Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/nanning-baolai-medical-instrument)

## Its most-cited devices
- K210367: D-Laser Blue, D-Laser 16 (2022), cited by 4
- K053555: Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L (2006), cited by 2
- K181087: Apex Locator, DPEX III (2018), cited by 2
- K212080: Imaging Plate Scanner, i-Scan (2021), cited by 1
- K203320: Endo Motor (2021), cited by 1
- K222569: Ai Ray Dental X-Ray Device (2022), cited by 1

## Recent decisions
- K251438: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (Sep 4, 2025)
- K222569: Ai Ray Dental X-Ray Device (Nov 23, 2022)
- K211358: Implanter incl. Accessories (Nov 21, 2022)
- K221548: Dental Air Polishing Handpiece (Sep 28, 2022)
- K210367: D-Laser Blue, D-Laser 16 (Mar 10, 2022)
- K203706: Dental Electric Motor (Jan 13, 2022)
- K211531: Cordless Prophy System, Model: i-Polish (Dec 17, 2021)
- K203615: Dental Scaler and Air Polisher (Dec 10, 2021)

Source page: https://510kreport.com/company/guilin-woodpecker-medical-instrument