510(k) K153291— SICAT OPTISLEEP

Substantially Equivalent

Sicat GmbH & Co. KG

Clearance details

Applicant: Sicat GmbH & Co. KG
Product code: Code LRK
Advisory panel: Dental
Date received: 2015-11-13
Decision date: 2016-03-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bonn, DE

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.