
Straumann USA, LLC
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Straumann CARES Titanium Alloy (TAN) Abutment is an FDA 510(k)-cleared medical device (K150899) manufactured by Straumann USA, LLC. 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 15, 2015. Regulation: 8.