510(k) Report

Devices descending from K191497

13 later devices reach NextDent Denture 3D+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243356Asiga DentaBASEAsiga Pty, Ltd.20250—
+1K250946Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.20250—
+1K231388NextDent BaseVertex-Dental B.V.20231—
+1K230098Trusana™Myerson, LLC20230—
+1K210298GR-14 Resin SystemPro3Dure Medical GmbH20213—
+1K203641E-Denture ProEnvisiontec GmbH20213—
+2K241089KeyPrint KeyDenture BaseKeystone Industries20242—
+2K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+2K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20222—
+3K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.20260—
+3K250489FP3DKeystone Industries20251—
+3K241493Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20240—
+4K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—