
Lifecore Biomedical, Inc.
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HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K950624) 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 August 29, 1995. Regulation: 8.