SIS SINUS IMPLANT STABILIZER— 510(k) K062436

Substantially Equivalent

Mondeal Medical Systems GmbH

FDA 510(k) clearance K062436 for SIS SINUS IMPLANT STABILIZER, Substantially Equivalent on 2007-07-30. Applicant: Mondeal Medical Systems GmbH.

Clearance details

Applicant: Mondeal Medical Systems GmbH
Product code: Code JEY
Advisory panel: Dental
Date received: 2006-08-21
Decision date: 2007-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.