ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L

ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L is an FDA 510(k)-cleared medical device (K991946) manufactured by Sterilex Corp.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 2, 1999. Regulation: 8.