510(k) Report

Devices descending from K032892

35 later devices reach Modification to Trubyte Denture Base Resin System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143033Dentca Denture BaseDentca, Inc.201530—
+1K072713Ion Dental Resin SystemDentsply International, Inc.20070—
+1K062333LaimadSteven Lamberg, D.D.S20062—
+2K220979SprintRay Denture BaseSprintray, Inc.20221—
+2K162572NextDent Denture, E-DentureVertex-Dental B.V.201728—
+2K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+2K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+3K260569DB 4000 High Impact Denture BaseCarbon, Inc.20260—
+3K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+3K200461Freeprint dentureDetax GmbH & Co. KG20203—
+3K191497NextDent Denture 3D+Vertex-Dental B.V.201913—
+3K190043Halley resinDentsply Sirona20197—
+3K181220Juell 3D Volo BasePark Dental Research Corporation20180—
+4K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc.20250—
+4K252430Freeprint® denture flexDetax GmbH20250—
+4K243356Asiga DentaBASEAsiga Pty, Ltd.20250—
+4K250946Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.20250—
+4K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd.20240—
+4K231388NextDent BaseVertex-Dental B.V.20231—
+4K230098Trusana™Myerson, LLC20230—
+4K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc.20222—
+4K210298GR-14 Resin SystemPro3Dure Medical GmbH20213—
+4K203641E-Denture ProEnvisiontec GmbH20213—
+4K191427Halley resin systemDentsply Sirona20193—
+5K260376Denture BaseShandong Huge Dental Material Corporation20260—
+5K241089KeyPrint KeyDenture BaseKeystone Industries20242—
+5K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+5K231578Lucitone Digital Print Denture SystemDentsply Sirona20232—
+5K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20222—
+6K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.20260—
+6K262300Denture Base Resin V2Formlabs Ohio, Inc.20260—
+6K250489FP3DKeystone Industries20251—
+6K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.20240—
+6K241493Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20240—
+7K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—