TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)— 510(k) K120218
Substantially EquivalentPalm Beach Dental Supply D/B/A Tek USA
FDA 510(k) clearance K120218 for TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE), Substantially Equivalent on 2012-06-29. Applicant: Palm Beach Dental Supply D/B/A Tek USA.
Clearance details
- Applicant
- Palm Beach Dental Supply D/B/A Tek USA
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pompano Beach, FL, 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.