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Straumann USA (On Behalf of Institut Straumann Ag)
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STRAUMANN MEMBRAGEL is an FDA 510(k)-cleared medical device (K101956) manufactured by Straumann USA (On Behalf of Institut Straumann Ag). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2010. Regulation: 8.