510(k) Report

Devices descending from K162044

16 later devices reach Dentca Denture Base II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221678SprintRay High Impact Denture BaseSprintray, Inc.20225—
+1K222414Tera Harz DentureGraphy, Inc.20220—
+1K210298GR-14 Resin SystemPro3Dure Medical GmbH20213—
+1K200580FotoDent dentureDreve Dentamid GmbH20201—
+1K193623DIOnavi-DentureDio Corporation20201—
+1K191591BB Base 3D printing resin for denture baseEnlighten Materials Co., Ltd.20200—
+2K260376Denture BaseShandong Huge Dental Material Corporation20260—
+2K243103Denture BaseRiton 3D Technology Co., Ltd.20240—
+2K233995Ivotion Base PrintIvoclar Vivadent, Inc.20240—
+2K230445OnX ToughSprintray, Inc.20232—
+2K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20222—
+2K210828DIOnavi-Denture02Dio Corporation20210—
+3K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.20260—
+3K262681NanoCeram Resin3BFAB Teknoloji a.S.20260—
+3K241493Glidewell™ 3DP Denture Base ResinPrismatik Dentalcraft, Inc.20240—
+3K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak20241—