K241354 is an FDA 510(k) clearance for the Sealer Solvent. This device is classified as a Cleanser, Root Canal.
Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on August 27, 2024, 106 days after receiving the submission on May 13, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K241354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2024 |
| Decision Date | August 27, 2024 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |