510(k) Report

Devices descending from K192596

8 later devices reach ULab Systems Dental Aligner Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.20250—
+1K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+1K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC20220—
+1K212680LuxCreo Clear Aligner SystemLuxCreo, Inc.20223—
+2K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+2K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+2K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—
+2K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—