Ceramill A-Splint— 510(k) K191836

Substantially Equivalent

Amann Girrbach AG

FDA 510(k) clearance K191836 for Ceramill A-Splint, Substantially Equivalent on 2019-12-20. Applicant: Amann Girrbach AG.

Clearance details

Applicant: Amann Girrbach AG
Product code: Code MQC
Advisory panel: Unknown
Date received: 2019-07-09
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Koblach, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.