DESS Dental Smart Solutions— 510(k) K253804
Substantially EquivalentTerrats Medical SL
FDA 510(k) clearance K253804 for DESS Dental Smart Solutions, Substantially Equivalent on 2026-04-16. Applicant: Terrats Medical SL. Device class: 2.
Summary
Terrats Medical's DESS Dental Smart Solutions is filed under product code NHA (Abutment, Implant, Dental, Endosseous). The name is generic, and the record doesn't describe the product beyond it and that code name.
Class II, 21 CFR 872.3630. It came in as a Traditional 510(k), and Dental is both the classification panel and the review panel.
Terrats Medical filed from Barcelona, Spain. Review took 139 calendar days (November 28, 2025 to April 16, 2026).
Clearance details
- Applicant
- Terrats Medical SL
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
Recent devices under product code NHA
view allMore clearances from Terrats Medical SL
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.