K251148 is an FDA 510(k) clearance for the JDEvolution Plus L and JDEvolution Plus LE. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Jdentalcare Srl (Modena, IT). The FDA issued a Cleared decision on September 25, 2025, 164 days after receiving the submission on April 14, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K251148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2025 |
| Decision Date | September 25, 2025 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |