
Aerobine, Inc.
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DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING is an FDA 510(k)-cleared medical device (K101717) manufactured by Aerobine, Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 19, 2010. Regulation: 8.