tün® ultrasonic tips product family— 510(k) K182145
Substantially EquivalentEngineered Endodontics
FDA 510(k) clearance K182145 for tün® ultrasonic tips product family, Substantially Equivalent on 2019-06-07. Applicant: Engineered Endodontics.
Clearance details
- Applicant
- Engineered Endodontics
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menomonee Falls, WI, US
Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
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.