IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID is an FDA 510(k)-cleared medical device (K964271) manufactured by Airel-West. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 18, 1997. Regulation: 8.