T1/T2/T3 TURBINE FAMILY— 510(k) K131319

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K131319 for T1/T2/T3 TURBINE FAMILY, Substantially Equivalent on 2014-05-30. Applicant: Sirona Dental Systems GmbH.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2013-05-07
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.