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Doxa Certex AB
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DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C is an FDA 510(k)-cleared medical device (K011839) manufactured by Doxa Certex AB. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2002. Regulation: 8.