510(k) K170849— SIMPLANT Guide
Substantially EquivalentDentsply Sirona
Clearance details
- Applicant
- Dentsply Sirona
- Product code
- Code NDP
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Adverse events under product code NDP
product code NDP- Injury
- 454
- Malfunction
- 1,956
- Total
- 2,410
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.