K250639 is an FDA 510(k) clearance for the DESS Dental Smart Solutions. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Terrats Medical SL (Barcelona, ES). The FDA issued a Cleared decision on May 22, 2025, 80 days after receiving the submission on March 3, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K250639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2025 |
| Decision Date | May 22, 2025 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA — Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |