THERMOFORMED MOUTHGUARDS— 510(k) K121365
Substantially EquivalentGlidewell Laboratories-Sleep Devices Group
FDA 510(k) clearance K121365 for THERMOFORMED MOUTHGUARDS, Substantially Equivalent on 2012-11-20. Applicant: Glidewell Laboratories-Sleep Devices Group.
Clearance details
- Applicant
- Glidewell Laboratories-Sleep Devices Group
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
Source: openFDA MAUDE database, through . 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.