510(k) Report

Devices descending from K130076

18 later devices reach Promolux, Promolux HI, Weropress, Premeco PCS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140758M-PM-Disc (Pink)Merz Dental GmbH201417—
+2K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry20161—
+2K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG201514—
+3K230445OnX ToughSprintray, Inc.20232—
+3K230115Denture Base ResinAidite (Qinhuangdao) Technology Co., Ltd.20230—
+3K210977E-Dent 1000Envisiontec GmbH20217—
+3K191926VITA VIONIC BondVita Zanhnfabrik H. Rauter GmbH Co.20201—
+3K172683Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co.20180—
+4K262681NanoCeram Resin3BFAB Teknoloji a.S.20260—
+4K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+4K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak20241—
+4K232691PolibondZirkonzahn Srl20230—
+4K222623Digital CrownSprintray, Inc.20224—
+4K220771Stratasys TrueDentStratasys, Ltd.202215
+5K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+5K260661Midas RestoreSprintray, Inc.20260—
+5K242277Crown HTSprintray, Inc.20241—
+6K261246SRGC-06GC America, Inc.20260—