K211721 is an FDA 510(k) clearance for the PS System. This device is classified as a Handpiece, Air-powered, Root Canal Irrigation (Class I - General Controls, product code NYL).
Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on December 2, 2021, 181 days after receiving the submission on June 4, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200. To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation..
| 510(k) Number | K211721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2021 |
| Decision Date | December 02, 2021 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NYL - Handpiece, Air-powered, Root Canal Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |
| Definition | To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation. |