
Bio-Interfaces, Inc.
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BIO-APATITE 6140 HA PARTICLES is an FDA 510(k)-cleared medical device (K950567) manufactured by Bio-Interfaces, 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 May 8, 1995. Regulation: 8.