K200125

Substantially Equivalent

Thermoforming Sheet Materials

Applicant: Erkodent Erich Kopp GmbH
Product code: MQC
Advisory panel: Unknown
Date received: 2020-01-21
Decision date: 2020-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pfalzgrafenweiler, DE

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.