Silent Nite Sleep Appliance with the Glidewell Hinge— 510(k) K210694
Substantially EquivalentPrismatik Dentalcraft, Inc.
FDA 510(k) clearance K210694 for Silent Nite Sleep Appliance with the Glidewell Hinge, Substantially Equivalent on 2021-06-16. Applicant: Prismatik Dentalcraft, Inc..
Clearance details
- Applicant
- Prismatik Dentalcraft, Inc.
- Product code
- 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.