
Bioform, Inc.
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CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 is an FDA 510(k)-cleared medical device (K030682) manufactured by Bioform, 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 June 26, 2003. Regulation: 8.