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Biomaterials Korea, Inc.
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SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS is an FDA 510(k)-cleared medical device (K111809) manufactured by Biomaterials Korea, 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 September 25, 2011. Regulation: 8.