K200330 is an FDA 510(k) clearance for the RC-Prime Root Canal Preparation Cream. This device is classified as a Cleanser, Root Canal.
Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 6, 2020, 147 days after receiving the submission on February 10, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K200330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2020 |
| Decision Date | July 06, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |