The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Dental Air Polishing Handpiece.
| Device ID | K221548 |
| 510k Number | K221548 |
| Device Name: | Dental Air Polishing Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin City, CN 541004 |
| Contact | Xunxian Wu |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944843658902 | K221548 | 000 |
| 06944843658896 | K221548 | 000 |
| 06944843635101 | K221548 | 000 |
| 06944843611815 | K221548 | 000 |