
Globaldental, Inc.
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BBX1, BBX2, BBX1MO, BBX1MC is an FDA 510(k)-cleared medical device (K142846) manufactured by Globaldental, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2016. Regulation: 8.