PREMIER ULTRASONIC SCALER AND INSERTS— 510(k) K010195
Substantially EquivalentPremier Dental Products Co.
FDA 510(k) clearance K010195 for PREMIER ULTRASONIC SCALER AND INSERTS, Substantially Equivalent on 2001-04-17. Applicant: Premier Dental Products Co..
Clearance details
- Applicant
- Premier Dental Products Co.
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- King Of Prussia, 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.