K250279 is an FDA 510(k) clearance for the RC-SwiftPrep. This device is classified as a Cleanser, Root Canal.
Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on July 2, 2025, 152 days after receiving the submission on January 31, 2025.
This device falls under the Dental FDA review panel.
| 510(k) Number | K250279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2025 |
| Decision Date | July 02, 2025 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |