K024133

Substantially Equivalent

CLS-2000 UNIT

Applicant: Dentsply Intl.
Product code: FLE
Advisory panel: General Hospital
Date received: 2002-12-16
Decision date: 2003-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.