Panthera Occlusal Appliance— 510(k) K203596

Substantially Equivalent

Panthera Dental, Inc.

FDA 510(k) clearance K203596 for Panthera Occlusal Appliance, Substantially Equivalent on 2021-04-20. Applicant: Panthera Dental, Inc..

Clearance details

Applicant: Panthera Dental, Inc.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2020-12-09
Decision date: 2021-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

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.