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Nordiska Dental AB
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ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY is an FDA 510(k)-cleared medical device (K002810) manufactured by Nordiska Dental 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 October 30, 2000. Regulation: 8.