510(k) K212541

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix by Deltamed GmbH — Product Code EBI

K212541 is an FDA 510(k) premarket notification submitted by Deltamed GmbH for the device "3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix". The FDA issued a decision of Substantially Equivalent on January 10, 2022. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Deltamed GmbH has at least 5 other 510(k) clearances on record.