DAWN LOW SPEED HANDPIECE SYSTEM— 510(k) K821484
Substantially EquivalentYoung Dental Manufacturing Co. 1, LLC
FDA 510(k) clearance K821484 for DAWN LOW SPEED HANDPIECE SYSTEM, Substantially Equivalent on 1982-06-09. Applicant: Young Dental Manufacturing Co. 1, LLC.
Clearance details
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
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.