
Straumann USA
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STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM is an FDA 510(k)-cleared medical device (K112280) manufactured by Straumann USA. 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 15, 2011. Regulation: 8.