
Ora Innovations, Inc.
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AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 is an FDA 510(k)-cleared medical device (K983168) manufactured by Ora Innovations, Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 17, 1998. Regulation: 8.