K062856
Substantially EquivalentTF ROTARY NICKEL TITANIUM FILE
- Applicant
- Ormco Corp.
- Product code
- EKS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, US
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.