K190394
Substantially EquivalentSunClear Aligner system
- Applicant
- Sun Dental Laboratories, LLC
- Product code
- NXC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
Adverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
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.