
Prismatik Dentalcraft, Inc.
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Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems is an FDA 510(k)-cleared medical device (K240240) manufactured by Prismatik Dentalcraft, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2024. Regulation: 8.