510(k) Report

Devices descending from K062432

59 later devices reach Nanotite Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+1K101545Genesis Implant SystemKeystone Dental2010153
+1K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+2K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+2K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+2K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+2K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+2K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+2K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K122300T3 Dental ImplantBiomet 3i2013223
+3K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K142426EBI External Implant SystemEbi, Inc.20150—
+4K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+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—
+5K211872PiezoImplant SystemRex Implants, Inc.20220—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K1505713i T3 Short ImplantsBiomet 3i20151—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—