QUANTEC SERIES 2000 ENDODONTIC FILES— 510(k) K962031
Substantially EquivalentTycom Dental
FDA 510(k) clearance K962031 for QUANTEC SERIES 2000 ENDODONTIC FILES, Substantially Equivalent on 1996-06-04. Applicant: Tycom Dental.
Clearance details
- Applicant
- Tycom Dental
- Product code
- Code EKS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code EKS
product code EKS- Malfunction
- 1,949
- Total
- 1,949
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.