510(k) Report

Devices descending from K111216

21 later devices reach Osseotite 2 Dental Implants through their predicates, nearest generation first.

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