510(k) Report

Devices descending from K951111

80 later devices reach Restore Self Tapping Dental Implant System (3.4MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc.2005405
+1K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543—
+1K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.20161—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K133050One Plus Implant SystemOsseofuse, Inc.20141—
+2K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+2K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas201131
+2K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+2K101545Genesis Implant SystemKeystone Dental2010153
+2K081226Simpact Implant SystemSimpact, LLC20081—
+2K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+2K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+2K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+2K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc.200702
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+2K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+2K053478Endosseous Dental Implant SystemNorthern Implants, LLC200630—
+2K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+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—
+3K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+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—
+3K161177Axiom PXAnthogyr Sas20170—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+3K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+3K141450AXIOM 2.8Anthogyr Sas201401
+3K131066Axiom RegAnthogyr Sas20142—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+3K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+3K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+3K110337Universal Maxillary MolarOco Biomedical20121—
+3K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+3K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+3K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+3K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+3K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+4K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—