
Nobel Biocare Uas, Inc.
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REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE is an FDA 510(k)-cleared medical device (K023952) manufactured by Nobel Biocare Uas, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2003. Regulation: 8.