510(k) Report

Devices descending from K011560

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062333LaimadSteven Lamberg, D.D.S20062—
+1K061580Eclipse Wax RemoverDentsply International20060—
+1K032892Modification to Trubyte Denture Base Resin SystemDentsply Intl.200335—
+2K143033Dentca Denture BaseDentca, Inc.201530—
+2K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+2K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+2K072713Ion Dental Resin SystemDentsply International, Inc.20070—
+3K220979SprintRay Denture BaseSprintray, Inc.20221—
+3K162572NextDent Denture, E-DentureVertex-Dental B.V.201728—
+4K260569DB 4000 High Impact Denture BaseCarbon, Inc.20260—
+4K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+4K200461Freeprint dentureDetax GmbH & Co. KG20203—
+4K191497NextDent Denture 3D+Vertex-Dental B.V.201913—
+4K190043Halley resinDentsply Sirona20197—
+4K181220Juell 3D Volo BasePark Dental Research Corporation20180—
+5K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc.20250—
+5K252430Freeprint® denture flexDetax GmbH20250—
+5K243356Asiga DentaBASEAsiga Pty, Ltd.20250—
+5K250946Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.20250—
+5K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd.20240—
+5K231388NextDent BaseVertex-Dental B.V.20231—
+5K230098Trusana™Myerson, LLC20230—
+5K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc.20222—
+5K210298GR-14 Resin SystemPro3Dure Medical GmbH20213—
+5K203641E-Denture ProEnvisiontec GmbH20213—
+5K191427Halley resin systemDentsply Sirona20193—
+6K260376Denture BaseShandong Huge Dental Material Corporation20260—
+6K241089KeyPrint KeyDenture BaseKeystone Industries20242—
+6K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+6K231578Lucitone Digital Print Denture SystemDentsply Sirona20232—
+6K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20222—
+7K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.20260—
+7K262300Denture Base Resin V2Formlabs Ohio, Inc.20260—
+7K250489FP3DKeystone Industries20251—
+7K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.20240—
+7K241493Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20240—
+8K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—