SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE— 510(k) K123161

Substantially Equivalent

Smartguard, Inc.

FDA 510(k) clearance K123161 for SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE, Substantially Equivalent on 2013-03-14. Applicant: Smartguard, Inc..

Clearance details

Applicant: Smartguard, Inc.
Product code: 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

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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.