K210694
Substantially EquivalentSilent Nite Sleep Appliance with the Glidewell Hinge
- Applicant
- Prismatik Dentalcraft, Inc.
- Product code
- LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.