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J.F. Jelenko & Co., Inc.
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JEL BIOS PURE is an FDA 510(k)-cleared medical device (K002645) manufactured by J.F. Jelenko & Co., 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 18, 2000. Regulation: 8.