DIAMONDCOAT ULTRASONIC INSERTS— 510(k) K030111
Substantially EquivalentDentsply International
FDA 510(k) clearance K030111 for DIAMONDCOAT ULTRASONIC INSERTS, Substantially Equivalent on 2003-02-07. Applicant: Dentsply International.
Clearance details
- Applicant
- Dentsply International
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- York, PA, 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.