
Jelenko Co.
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PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL is an FDA 510(k)-cleared medical device (K896915) manufactured by Jelenko 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 April 29, 1990. Regulation: 8.