510(k) Report

Devices descending from K181739

18 later devices reach Invisalign System with Mandibular Advancement Feature through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+1K220287Invisalign SystemAlign Technology, Inc.2022131
+1K192069Aerodentis SystemDror Orthodesign20201—
+2K253282ZSmile SystemDror Orthodesign, Ltd.20260—
+2K251758Serafin®Tns Co., Ltd.20250—
+2K250487SparkTM Clear Aligner SystemOrmco Corporation20250—
+2K232074Serafin®Tns Co., Ltd.20241—
+2K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231—
+2K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.20233—
+2K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.20221—
+2K222418NuvolaGruppo Europeo Ortodonzia Srl20222—
+3K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+3K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.20250—
+3K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.20250—
+3K242929Fas Aligner SystemXplora 3D Europe S.L20240—
+3K241412Invisalign SystemAlign Technology, Inc.20242—
+4K252380Invisalign SystemAlign Technology, Inc.20251—
+5K262196Invisalign SystemAlign Technology, Inc.20260—