THERMOFORMED MOUTHGUARDS— 510(k) K121365

Name: FDA 510(k) clearance K121365
Creator: U.S. Food and Drug Administration
Published: 2012-11-20

Substantially Equivalent

Glidewell Laboratories-Sleep Devices Group

FDA 510(k) clearance K121365 for THERMOFORMED MOUTHGUARDS, Substantially Equivalent on 2012-11-20. Applicant: Glidewell Laboratories-Sleep Devices Group. Device class: Unclassified.

Clearance details

Applicant: Glidewell Laboratories-Sleep Devices Group
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-05-07
Decision date: 2012-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.