
Takara Belmont USA, Inc.
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INTRAORAL BELSENSOR GOLD is an FDA 510(k)-cleared medical device (K102456) manufactured by Takara Belmont USA, 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 December 14, 2011. Regulation: 8.