510(k) Report

Devices descending from K143630

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220140ClearCorrect SystemClearcorrect, LLC20220—
+1K203737Spark Clear Aligner SystemOrmco Corporation202110—
+1K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc.201818—
+1K182826Ormco Spark Aligner SystemSybron Dental Specialties20186—
+1K171674Angel Align SystemSmile Development Corp20186—
+2K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+2K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+2K220287Invisalign SystemAlign Technology, Inc.2022131
+2K203688Clear AlignerWuxi EA Medical Instruments Technologies Limited.20213—
+2K212660Smylio Invisible Clear AlignersSmylio, Inc.20217—
+2K2106526MS Invisible AlignerSms Opco, LLC20210—
+2K210540Ohlendorf Clear AlignerOhlendorf Appliance Laboratory20211—
+2K203339NEOLab Clear AlignersNew England Ortho Lab, Inc.20210—
+2K202685Eon AlignerEon Dental Jordan, LLC20200—
+2K193130MVP Aligner SystemMvp Aligners, LLC20200—
+2K192069Aerodentis SystemDror Orthodesign20201—
+2K191990OSW Aligner SystemOsw Manufacturing, LLC20191—
+3K253282ZSmile SystemDror Orthodesign, Ltd.20260—
+3K251758Serafin®Tns Co., Ltd.20250—
+3K250487SparkTM Clear Aligner SystemOrmco Corporation20250—
+3K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.20241—
+3K241137Clear Moves AlignerClear Moves Aligners20240—
+3K232074Serafin®Tns Co., Ltd.20241—
+3K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231—
+3K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.20233—
+3K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.20221—
+3K222418NuvolaGruppo Europeo Ortodonzia Srl20222—
+3K220726K ClearKline Europe GmbH20221—
+3K211510uLab Systems Dental Aligner KitUlab Systems, Inc.20222—
+3K2002143D Predict3D Smile USA, Inc.20200—
+4K260527FACE4D AlignerAvinent Implant System S.L.U.20260—
+4K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+4K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—
+4K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.20250—
+4K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.20250—
+4K242929Fas Aligner SystemXplora 3D Europe S.L20240—
+4K241412Invisalign SystemAlign Technology, Inc.20242—
+4K223141STR8 Clear AlignerStr8 Oral Care20231—
+5K252380Invisalign SystemAlign Technology, Inc.20251—
+5K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)20240—
+6K262196Invisalign SystemAlign Technology, Inc.20260—