510(k) Report

Devices descending from K100724

27 later devices reach Osseotite II Model Xifossxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+1K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+1K122300T3 Dental ImplantBiomet 3i2013223
+1K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+2K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+2K142426EBI External Implant SystemEbi, Inc.20150—
+2K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+3K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+3K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+3K211872PiezoImplant SystemRex Implants, Inc.20220—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K1505713i T3 Short ImplantsBiomet 3i20151—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—