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Bio-Lok Intl., Inc.
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MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS is an FDA 510(k)-cleared medical device (K041136) 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 October 21, 2004. Regulation: 8.