K211531 is an FDA 510(k) clearance for the Cordless Prophy System, Model: i-Polish. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on December 17, 2021, 214 days after receiving the submission on May 17, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K211531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2021 |
| Decision Date | December 17, 2021 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |