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Apoza Enterprise Co., Ltd.
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APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W is an FDA 510(k)-cleared medical device (K070373) manufactured by Apoza Enterprise 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 March 1, 2007. Regulation: 8.