510(k) Report

Devices descending from K034035

15 later devices reach 3I Patient-Specific Overdenture Bar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080864Cam Structsure Precision Milled BarsBiomet 3i, Inc.200814—
+2K180998BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc.20189—
+2K173466Panthera Dental Milled BarsPanthera Dental, Inc.20182—
+2K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K192108Panthera Dental Milled BarsPanthera Dental, Inc.20200—
+3K183580Panthera Dental Milled BarsPanthera Dental, Inc.20190—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—