510(k) K242897

Partial Flex by Clemde SA DE CV — Product Code EBI

K242897 is an FDA 510(k) premarket notification submitted by Clemde SA DE CV for the device "Partial Flex". The FDA issued a decision of Substantially Equivalent on June 3, 2025. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Clemde SA DE CV has at least 1 other 510(k) clearance on record.