
Bio-Lok Intl., Inc.
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SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) is an FDA 510(k)-cleared medical device (K032454) manufactured by Bio-Lok Intl., 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 March 3, 2004. Regulation: 8.