MOUTHGUARD AND ALIGNER MATERIALS— 510(k) K062828

Substantially Equivalent

Dentsply Intl., Inc.

FDA 510(k) clearance K062828 for MOUTHGUARD AND ALIGNER MATERIALS, Substantially Equivalent on 2006-11-27. Applicant: Dentsply Intl., Inc..

Clearance details

Applicant: Dentsply Intl., Inc.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2006-09-20
Decision date: 2006-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.