DESS Dental Smart Solutions— 510(k) K260564
Substantially EquivalentTerrats Medical SL
FDA 510(k) clearance K260564 for DESS Dental Smart Solutions, Substantially Equivalent on 2026-06-09. Applicant: Terrats Medical SL. Device class: 2.
Summary
Terrats Medical's DESS Dental Smart Solutions is filed under NHA, endosseous dental implant abutments. The name is generic, and the record doesn't list the abutments it covers.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Terrats filed from Barcelona, Spain. The decision came 110 calendar days after receipt (February 19 to June 9, 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.