510(k) Report

Devices descending from K191123

11 later devices reach Multi-unit Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231566ICX-Implant SystemMedentis Medical GmbH20240—
+1K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+1K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+1K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+2K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+2K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+3K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+3K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+3K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+3K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+4K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—