510(k) Report

Devices descending from K994376

665 later devices reach Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl.20080—
+1K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+1K0306143I Dental ImplantsImplant Innovations, Inc.2003319—
+1K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH2003391—
+1K030639Xive 3.0 Dental Implant SystemFriandent GmbH20039—
+1K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002583—
+2K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+2K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+2K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc.20072115
+2K062197Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ AbutmentAtlantis Components, Inc.20070—
+2K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007361—
+2K050970Milo Dental Implant SystemIntra-Lock International20057—
+2K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+2K040170Friadent Plus Dental Implant SystemsFriadent GmbH200484—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+2K032750Modification to: Xive 3.0 Dental Implant System, MultipleFriandent GmbH200303
+2K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc.2003320—
+2K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003330—
+2K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002478—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+3K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+3K131701Z5MLB, Z5MLCZ-Systems AG20131—
+3K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+3K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+3K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+3K122300T3 Dental ImplantBiomet 3i2013223
+3K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+3K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+3K112787KeratorKj Meditech Co., Ltd.20123—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+3K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+3K100724Osseotite II Model XifossxxxBiomet 3i, Inc.2011275
+3K093749GC Aadva Implant SystemGC America, Inc.20100—
+3K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+3K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+3K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K083669OBIEuroteknika20090—
+3K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+3K072425Jne Implant SystemGC America, Inc.20081—
+3K072363Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc.200835—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K070935T.B.R. ZirconnectSudimplant SA20070—
+3K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007357—
+3K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc.200720910
+3K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+3K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+3K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+3K062432Nanotite Dental ImplantsImplant Innovations, Inc.200759—
+3K052254Mytis Arrow XXXXBrainbase Corporation20060—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K050956TBR Idea Conic/ConicSudimplant SA20062—
+3K051189Prevail Dental ImplantsImplant Innovations, Inc.2005317—
+3K040757Sic ProSic Invent AG20052—
+3K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491—
+3K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd.2004218—
+3K0334303I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611…Implant Innovations, Inc.2003213—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K211872PiezoImplant SystemRex Implants, Inc.20220—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K200386Z5-BLZ-Systems AG20200—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—