510(k) K250302

Flexible Partial Resin by Prismatik Dentalcraft, Inc. — Product Code EBI

K250302 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Flexible Partial Resin". The FDA issued a decision of Substantially Equivalent on June 25, 2025. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.