3.0 Dynamic TiBase— 510(k) K162021

Substantially Equivalent

Talladium Espana, SL

FDA 510(k) clearance K162021 for 3.0 Dynamic TiBase, Substantially Equivalent on 2018-05-04. Applicant: Talladium Espana, SL.

Clearance details

Applicant: Talladium Espana, SL
Product code: Code NHA
Advisory panel: Dental
Date received: 2016-07-21
Decision date: 2018-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lleida, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.