510(k) Report

Devices descending from K162572

28 later devices reach NextDent Denture, E-Denture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+1K200461Freeprint dentureDetax GmbH & Co. KG20203—
+1K191497NextDent Denture 3D+Vertex-Dental B.V.201913—
+1K190043Halley resinDentsply Sirona20197—
+1K181220Juell 3D Volo BasePark Dental Research Corporation20180—
+2K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc.20250—
+2K252430Freeprint® denture flexDetax GmbH20250—
+2K243356Asiga DentaBASEAsiga Pty, Ltd.20250—
+2K250946Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.20250—
+2K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd.20240—
+2K231388NextDent BaseVertex-Dental B.V.20231—
+2K230098Trusana™Myerson, LLC20230—
+2K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc.20222—
+2K210298GR-14 Resin SystemPro3Dure Medical GmbH20213—
+2K203641E-Denture ProEnvisiontec GmbH20213—
+2K191427Halley resin systemDentsply Sirona20193—
+3K260569DB 4000 High Impact Denture BaseCarbon, Inc.20260—
+3K260376Denture BaseShandong Huge Dental Material Corporation20260—
+3K241089KeyPrint KeyDenture BaseKeystone Industries20242—
+3K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+3K231578Lucitone Digital Print Denture SystemDentsply Sirona20232—
+3K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20222—
+4K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.20260—
+4K262300Denture Base Resin V2Formlabs Ohio, Inc.20260—
+4K250489FP3DKeystone Industries20251—
+4K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.20240—
+4K241493Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20240—
+5K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—