510(k) K262239

Obsidian® Press Over Zirconia by Prismatik Dentalcraft, Inc. — Product Code EIH

K262239 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Obsidian® Press Over Zirconia". The FDA issued a decision of Substantially Equivalent on July 30, 2026. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.