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
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+5K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K150040ImplanovaDental Evolutions, Inc.20150—
+5K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+5K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+5K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+5K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+5K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+5K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+5K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc.2011202—
+5K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+5K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+5K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+5K090174Tsi; EriOco Biomedical20094—
+5K071148Atlas Implant SystemCowellmedi Co., Ltd.20084—
+5K070562EZ Plus Implant SystemMegagen Co., Ltd.200774—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+6K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—