Star E900 Handpiece Series— 510(k) K240183
Substantially EquivalentDentalez, Inc., Stardental Division
FDA 510(k) clearance K240183 for Star E900 Handpiece Series, Substantially Equivalent on 2024-09-19. Applicant: Dentalez, Inc., Stardental Division.
Clearance details
- Applicant
- Dentalez, Inc., Stardental Division
- Product code
- Code EGS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancaster, PA, US
Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
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.