Dorsal Appliance— 510(k) K143591
Substantially EquivalentGergens Orthodontic Lab
FDA 510(k) clearance K143591 for Dorsal Appliance, Substantially Equivalent on 2015-04-15. Applicant: Gergens Orthodontic Lab.
Clearance details
- Applicant
- Gergens Orthodontic Lab
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
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.