K123161

Substantially Equivalent

SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

Applicant: Smartguard, Inc.
Product code: MQC
Advisory panel: Unknown
Date received: 2012-10-09
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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.