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Takara Belmont USA, Inc.
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ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM is an FDA 510(k)-cleared medical device (K041834) 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 2, 2004. Regulation: 8.