510(k) Report

Devices descending from K943168

130 later devices reach Clearfil AP-X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042548Cerasys - ZRCerasys, Inc.20040—
+1K012740Clearfil AP-XKuraray Medical, Inc.200135—
+1K984201DenzirDentronic AB199993—
+2K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc.20152—
+2K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc.20150—
+2K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc.20154—
+2K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc.20130—
+2K111982Clearfil DC Core PlusKuraray America, Inc.20116—
+2K073568PSL Biozir BlockP.S.L. International, Inc.20080—
+2K063842Cyrtina SystemOratio B.V.20070—
+2K070045Zirblank-PS and Zirblank-FSAcucera, Inc.20072—
+2K063595Clearfil Majesty PosteriorKuraray America, Inc.20074—
+2K063593Clearfil Majesty FlowKuraray America, Inc.200717—
+2K062695Sagemax Z-BlankSagemax Bioceramics, Inc.200676—
+2K061860Clearfil Majesty EstheticKuraray Medical, Inc.200611—
+2K043472Medin Tech Zirconia-CP10, SS1000Medin Tech200580—
+2K042124DenfilVericom Co., Ltd.20044—
+2K041645DDS-ZRCharles Scharf20048—
+2K023327Cynovad ZirkonCynovad200291—
+2K023002Clearfil AP-X PLTKuraray Medical, Inc.20029—
+2K022999Clearfil AP-X PLT Intro KitKuraray Medical, Inc.20020—
+3K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.20210—
+3K193496CharmFilDentkist, Inc.20200—
+3K192510DIAFIL & DIAFIL CapsuleDiaDent Group International20202—
+3K192178R&D Series Nova Compo NImicryl Dis Malzemeleri Sanayi VE Ticaret AS20190—
+3K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG20190—
+3K183537PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc.20190—
+3K162967nuance UNIVERSALDen-Mat Holdings, LLC20170—
+3K130991Nexxzr (TM)T and Nexxzr (TM)SSagemax Bioceramics, Inc.20147—
+3K130198Neo Denta ZirconiaNeo Group Limited20130—
+3K130371Clearfil Majesty ES FlowKuraray Noritake Dental, Inc.20130—
+3K121583Clearfil Majesty FlowKuraray Noritake Dental, Inc.20123—
+3K111975Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKuraray Medical, Inc.20110—
+3K111980Clearfil Tri-S Bond PlusKuraray America, Inc.20114—
+3K100328Clearfil Majety PosteriorKuraray Medical, Inc.20100—
+3K092630ZIROXZencera, Inc.20091—
+3K083201Zmatch BlockDentaim Co., Ltd.20091—
+3K082652Bittar Zirconia BlocksBittar Zirconia Block, LLC20080—
+3K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc.200843—
+3K081263StarceramH.C. Starck Ceramics GmbH & Co.Kg200817—
+3K081253Zirdent Cad/Cam BlocksC5 Medical Werks, Inc.20081—
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc.20071—
+3K070325Clearfil Majesty Esthetic PLTKuraray Medical, Inc.20070—
+3K033970Clearfil Photo Core PLTKuraray Medical, Inc.20040—
+4K261093DiafilDiaDent Group International20260—
+4K2108841Derful HS, 1Derful HT1derful, Inc.20210—
+4K210421Diafil & Diafil CapsuleDiaDent Group International20210—
+4K193090HCG Zirconia Ceramic BlockHocheng Corporation20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K182430Clearfil Majesty ICKuraray Noritake Dental, Inc.20190—
+4K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…Swissmeditec GmbH20170—
+4K142043Insync ZR High Translucency ZirconiaJensen Industries, Inc.20140—
+4K133213StarceramH.C. Starck Ceramics GmbH20133—
+4K132450Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…Kuraray Noritake Dental, Inc.20131—
+4K131432Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack…Kuraray Noritake Dental, Inc.20131—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K100250XceramXceramusa20100—
+4K093571ZR Dental BlockAms Co., Ltd.20100—
+4K093748DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt)201013—
+4K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd.201041—
+4K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc.20090—
+4K091852Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205Refractron Technologies Corp.20090—
+4K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc.20090—
+5K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseImicryl Dis Malzemeleri Sanayi VE Ticaret AS20210—
+5K202673X-cera Pre-shaded Zirconia BlanksDongguan Xiangtong Co., Ltd.20200—
+5K152175Upcera Dental Zirconia Blank for Aesthetic RestorationLiaoning Upcera Co., Ltd.20154—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K143656StarCeram® Z-Nature, StarCeram® Z-SmileH.C. Starck Ceramics GmbH20150—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143071Nacera PearlDoceram Medical Ceramics GmbH20150—
+5K150196DD cubeX2Dental Direkt GmbH20159—
+5K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt)20157—
+5K141724Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd.201425—
+5K140924StarceramH.C. Starck Ceramics GmbH20141—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K122972CDC Zirconia BlanksContinental Dental Ceramics, Inc. (Dba Continental20120—
+5K120852Zirconia Blanks (Zircostar)Kerox, Ltd.20120—
+5K111291Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd.20117—
+6K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.20260—
+6K241579DD Hybridlayer (multicolored zirconia)Dental Direkt GmbH20240—
+6K241602Kingcera Dental Zirconia BlankHunan Qinghao Puzhong Technology Co., Ltd.20240—
+6K240672Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT…Zhejiang Zahndent Biotechnology Co., Ltd.20240—
+6K240912Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd.20240—
+6K240772Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)Hunan Ceramaster Material Technology Co., Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K231687Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd.20232—
+6K230003Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankTopzir Biotech Co., Ltd.20230—
+6K222520Zirconia BlockYilink (Tianjin) Biotechnology Co., Ltd.20220—
+6K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHunan Vsmile Biotechnology Co., Ltd.20220—
+6K221051Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankChangsha Honchon Technology Co., Ltd.20220—
+6K213570Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.20220—
+6K212259Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirdent New Material Co., Ltd.20210—
+6K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.20214—