
Lifecore Biomedical, Inc.
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PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS is an FDA 510(k)-cleared medical device (K050506) manufactured by Lifecore Biomedical, 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 April 14, 2005. Regulation: 8.