510(k) Report

Devices descending from K180241

15 later devices reach Orthocaps Twinaligner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191838Clearform AlignersMotor City Lab Works20203—
+1K2002143D Predict3D Smile USA, Inc.20200—
+1K192596ULab Systems Dental Aligner KitUlab Systems, Inc.20208—
+1K190948Magic Clear AlignersVoodoo Manufacturing, Inc.20190—
+2K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.20250—
+2K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+2K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC20220—
+2K212680LuxCreo Clear Aligner SystemLuxCreo, Inc.20223—
+2K202792BRIUS Clear AlignersBrius Technologies, Inc.20212—
+3K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+3K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+3K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—
+3K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+3K233152GENIOVA alignersGeniova Technologies Sociedad Limitada20240—
+3K220835ArklignersArklign Laboratories20220—