510(k) Report

Devices descending from K220287

13 later devices reach Invisalign System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251758Serafin®Tns Co., Ltd.20250—
+1K232074Serafin®Tns Co., Ltd.20241—
+1K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231—
+1K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.20233—
+1K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.20221—
+1K222418NuvolaGruppo Europeo Ortodonzia Srl20222—
+2K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+2K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.20250—
+2K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.20250—
+2K242929Fas Aligner SystemXplora 3D Europe S.L20240—
+2K241412Invisalign SystemAlign Technology, Inc.20242—
+3K252380Invisalign SystemAlign Technology, Inc.20251—
+4K262196Invisalign SystemAlign Technology, Inc.20260—