Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guilin Woodpecker Medical Instrument Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
214 daysmedian FDA review time
395 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 | 118 | 0 |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-23 | 91 | 0 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 | 567 | 0 |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-09-28 | 124 | 0 |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-03-10 | 395 | 0 |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-01-13 | 391 | 0 |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-17 | 214 | 0 |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-10 | 365 | 0 |
| K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-09-27 | 87 | 0 |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-05-10 | 179 | 0 |
| K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 | 237 | 0 |
| K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | 2011-11-18 | 196 | 0 |
| K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | 2008-03-19 | 75 | 0 |
| K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS- | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006-08-21 | 244 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda