
Straumann USA
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TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS is an FDA 510(k)-cleared medical device (K122855) 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 December 11, 2012. Regulation: 8.