S-FILE, S-FINDER, S-ENGINE FILE— 510(k) K892894
Substantially EquivalentSvenska Dental Instruments AB
FDA 510(k) clearance K892894 for S-FILE, S-FINDER, S-ENGINE FILE, Substantially Equivalent on 1989-05-24. Applicant: Svenska Dental Instruments AB.
Clearance details
- Applicant
- Svenska Dental Instruments AB
- Product code
- Code EKS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sweden, SE
Adverse events under product code EKS
product code EKS- Malfunction
- 1,949
- Total
- 1,949
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.