510(k) K260569

DB 4000 High Impact Denture Base by Carbon, Inc. — Product Code EBI

K260569 is an FDA 510(k) premarket notification submitted by Carbon, Inc. for the device "DB 4000 High Impact Denture Base". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760.