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Dxm Co., Ltd.
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D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 is an FDA 510(k)-cleared medical device (K121093) manufactured by Dxm Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 2012. Regulation: 8.