510(k) Report

Devices descending from K013067

568 later devices reach Frialoc Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+4K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K093615Spi Dental Implant, ElementThommen Medical AG20101—
+4K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+4K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+4K072425Jne Implant SystemGC America, Inc.20081—
+4K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+4K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+4K053088Slactive ImplantsInstitut Straumann AG2006295—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+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—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K193352AbutmentCADExocad GmbH20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K200100Abutment Design3Shape A/S20203—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+5K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K162299Spiral Shape Dental Implant SystemGp Implants20173—
+5K161177Axiom PXAnthogyr Sas20170—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K160786RODO Abutment SystemRodo Medical, Inc.20162—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+5K160244VARIOuniteThommen Medical AG201615—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150295LOCATOR RTxZest Anchors, Inc.201542—
+5K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—