430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES is an FDA 510(k)-cleared medical device (K130455) manufactured by Dentalez Group, Stardental Division. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 24, 2013. Regulation: 8.