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
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K173575OsteoReady Dental Implant SystemOsteoready, LLC20180—
+4K180598UNIQA Dental Implants SystemUniqa Dental, Ltd.20181—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K170131TAV Medical Dental Implants SystemTav Medical, Ltd.20181—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants20170—
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161593GMI Frontier Dental Implant SystemIlerimplant S.L20170—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K160119NobelSpeedy GroovyNobel Biocare AB20167—
+4K160244VARIOuniteThommen Medical AG201615—
+4K1505713i T3 Short ImplantsBiomet 3i20151—
+4K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+4K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K133991ISYAltatec GmbH20142—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K112162Conical Connection ImplantsMis Implants Technologies, Ltd.20122—
+4K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+4K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+4K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K090709Cortex Dental Implant SystemCortex Dental Implants Industries, Ltd.20090—
+4K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K082749Omni-TightBasic Dental Implant Systems, Inc.20080—
+4K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc.2008337—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+4K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+4K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+4K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc.2007209—
+4K063106Revois Implant SystemCurasan AG20072—
+4K061323Modification to Reliadent Dental Implant SystemBioinfera, Inc.20072—
+4K070022Mistral - One Stage Screw-Type Dental Implant, Model MF9Mis Implants Technologies, Ltd.20072—
+4K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K052369Exfeel Implant SystemMegagen Co., Ltd.200684—
+4K050635Allfim Implant SystemsCowellmedi Co., Ltd.20055—
+4K043428Reliadent Dental Implant SystemBioinfera, Inc.20052—
+5K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—