K231990 is an FDA 510(k) clearance for the Apex Locator. This device is classified as a Locator, Root Apex.
Submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on February 13, 2024, 223 days after receiving the submission on July 5, 2023.
This device falls under the Dental FDA review panel.
| 510(k) Number | K231990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2023 |
| Decision Date | February 13, 2024 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY — Locator, Root Apex |
| Device Class | — |