510(k) Report

Devices descending from K894594

37 later devices reach Bonefit Hollow Screw Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.20161—
+2K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+2K053478Endosseous Dental Implant SystemNorthern Implants, LLC200630—
+2K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+3K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.20240—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+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—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+3K110337Universal Maxillary MolarOco Biomedical20121—
+3K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+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—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—