
Coors Biomedical Co.
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ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ is an FDA 510(k)-cleared medical device (K863176) manufactured by Coors Biomedical Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 1986. Regulation: 8.