510(k) Report

Devices descending from K010630

30 later devices reach Y-TZP Powder and Procera Allzirkon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032562Proceara Copings and PonticNobel Biocare AB200429—
+2K153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare AB20163—
+2K100512Nobelprocera Ips E.Max CrownNobel Biocare AB20101—
+2K060530SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…Lifecore Biomedical, Inc.200615—
+2K053068Procera Bridge Laminate, Model 40-4002Nobel Biocare AB20060—
+2K041283Procera Bridge ZirconiaNobel Biocare AB20045—
+3K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.20240—
+3K203072Franz Zirconia Dental CrownFranz Biotech, Inc.20220—
+3K162677L- OVCRhondium, Ltd.20160—
+3K162043NobelProcera HT ML FCZ BridgeNobel Biocare AB20160—
+3K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc.20090—
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+3K053050Procera Bridge AluminaNobel Biocare AB20061—
+3K053125Procera Bridge ZirconiaNobel Biocare AB20061—
+4K130184ZenoluxWieland Dental + Technik GmbH & Co. KG20130—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+4K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+4K071182Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013Nobel Biocare AB20070—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—