TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)

TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) is an FDA 510(k)-cleared medical device (K120218) manufactured by Palm Beach Dental Supply D/B/A Tek USA. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 28, 2012. Regulation: 8.