510(k) K240240

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems by Prismatik Dentalcraft, Inc. — Product Code NHA

K240240 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems". The FDA issued a decision of Substantially Equivalent on July 12, 2024. 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.