510(k) K231097

Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems by Prismatik Dentalcraft, Inc. — Product Code NHA

K231097 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems". The FDA issued a decision of Substantially Equivalent on November 14, 2023. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Prismatik Dentalcraft, Inc. has at least 10 other 510(k) clearances on record.