DOCTOR'S NIGHTGUARD— 510(k) K053580

Substantially Equivalent

Dental Concepts, LLC

FDA 510(k) clearance K053580 for DOCTOR'S NIGHTGUARD, Substantially Equivalent on 2006-03-03. Applicant: Dental Concepts, LLC.

Clearance details

Applicant: Dental Concepts, LLC
Product code: Code MQC
Advisory panel: Unknown
Date received: 2005-12-22
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.