
Straumann USA
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STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING is an FDA 510(k)-cleared medical device (K061277) 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 April 11, 2007. Regulation: 8.