510(k) Report

Devices descending from K973221

102 later devices reach Composite 168 Restorative System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133850Camouflage Nanohybrid Composite (Universal & Flowable)Prismatik Dentalcraft, Inc.20140—
+1K042548Cerasys - ZRCerasys, Inc.20040—
+1K040144Quixx Posterior RestorativeDentsply International20042—
+1K984201DenzirDentronic AB199993—
+1K984387R-30 Aesthetic RestorativeDentsply Intl.19993—
+2K073568PSL Biozir BlockP.S.L. International, Inc.20080—
+2K063842Cyrtina SystemOratio B.V.20070—
+2K070045Zirblank-PS and Zirblank-FSAcucera, Inc.20072—
+2K062695Sagemax Z-BlankSagemax Bioceramics, Inc.200676—
+2K053391X-Tra FilVoco GmbH20060—
+2K052097Ceram X Universal Mano-Ceramic RestorativeDentsply International20052—
+2K050880Dyract Extra RestorativeDentsply Intl.20050—
+2K043472Medin Tech Zirconia-CP10, SS1000Medin Tech200580—
+2K041645DDS-ZRCharles Scharf20048—
+2K023327Cynovad ZirkonCynovad200291—
+3K130991Nexxzr (TM)T and Nexxzr (TM)SSagemax Bioceramics, Inc.20147—
+3K130198Neo Denta ZirconiaNeo Group Limited20130—
+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—
+3K080305Nexcomp and Meta EtchantMeta Biomed Co., Ltd.20081—
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+4K2108841Derful HS, 1Derful HT1derful, Inc.20210—
+4K193090HCG Zirconia Ceramic BlockHocheng Corporation20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K181689NexcompMeta Biomed Co., Ltd.20180—
+4K142043Insync ZR High Translucency ZirconiaJensen Industries, Inc.20140—
+4K133213StarceramH.C. Starck Ceramics GmbH20133—
+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—
+4K091852Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205Refractron Technologies Corp.20090—
+4K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc.20090—
+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—
+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—
+6K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankVatech Acucera, Inc.20210—
+6K203351Perfit ZR HT Dental Zirconia blankVatech Acucera, Inc.20210—
+6K193055Purzir Dental Zirconia3DBiocad20200—
+6K182068Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd.20184—
+6K171585LUXEN Zr, LUXEN SmileDentalmax Co., Ltd.20185—
+6K163238Eclipse Kiss ZirconiaAms20170—
+6K160203Adamant Zirconia DiscAdamant Co., Ltd.20160—
+6K160367Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd.20166—
+6K153767X-cera Zirconia BlanksShenzhen Xiangtong Photoelectricity Technology Co., Ltd.20160—
+6K141162All-Ceramic Zirconia BlockRizhao Huge Dental Industry Co., Ltd.20140—
+7K262074Any-ZircosMediclus Co., Ltd.20260—
+7K253973Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP SeriesLiaoning Upcera Co., Ltd.20260—
+7K251593DenMat Multilayered Zirconia DiscDenmat Holding, LLC20250—
+7K241151Luxen 5GDentalmax Co., Ltd.20241—
+7K222686Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.20220—
+7K220816BruxZir NOWPrismatik Dentalcraft, Inc.20222—
+7K221429KDF Zirconia DiscDenken-Highdental Co., Ltd.20220—
+7K210097Estar-ZOsstem Implant Co., Ltd.20211—
+7K192262Dental Zirconia BlocksDe Corematrix Co., Ltd.20203—
+7K191631ZMAXX Dental Zirconia BlanksZmaxx Bioceramics, LLC20190—
+7K180252Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd.20184—
+8K252446BruxZir® NOWPrismatik Dentalcraft, Inc.20250—
+8K250223BruxZir® Esthetic NOWPrismatik Dentalcraft, Inc.20250—
+8K242521Estar-ZEOsstem Implant Co., Ltd.20240—
+8K233125Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd.20240—
+8K214005Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd.20220—
+8K190112Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd.20193—
+9K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd.20231—