DESS® Dental Implants— 510(k) K251280

Substantially Equivalent

Terrats Medical SL

FDA 510(k) clearance K251280 for DESS® Dental Implants, Substantially Equivalent on 2025-07-23. Applicant: Terrats Medical SL.

Clearance details

Applicant: Terrats Medical SL
Product code: Code DZE
Advisory panel: Dental
Date received: 2025-04-24
Decision date: 2025-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barberá Del Vallés, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.