FREEWAY COMFORT BITE GUARD— 510(k) K110468

Substantially Equivalent

Randmark Dental Products, LLC

FDA 510(k) clearance K110468 for FREEWAY COMFORT BITE GUARD, Substantially Equivalent on 2011-08-05. Applicant: Randmark Dental Products, LLC.

Clearance details

Applicant: Randmark Dental Products, LLC
Product code: Code MQC
Advisory panel: Unknown
Date received: 2011-02-17
Decision date: 2011-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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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.