510(k) Report

Devices descending from K081960

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222619EnsmileEnsmile Pvt, Ltd.20231—
+1K200908iSMILE3D Diagnostix, Inc.20202—
+1K1831593M Clarity Aligners3M Company20184—
+1K180241Orthocaps TwinalignerOrtho Caps GmbH201815—
+1K1636893M Clear Tray Aligner3M Unitek Corporation201713—
+1K151965Dentti SystemMartz, Inc.20160—
+1K143630Invisalign SystemAlign Technology, Inc.201541—
+1K143499eClignerEclear International Co., Ltd.20151—
+1K123925MTM Clear Aligner in-OfficeDentsply International, Inc.20132—
+2K233544MesheetDentis Co., Ltd.20240—
+2K221537Nightwear AlignersSmylio, Inc.20230—
+2K222308Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd.20220—
+2K220140ClearCorrect SystemClearcorrect, LLC20220—
+2K193622TRIOCLEAR SystemPerfection Aligner System Hong Kong Limited20211—
+2K203737Spark Clear Aligner SystemOrmco Corporation202110—
+2K201104AsoAlignerAso International Manila, Inc.20210—
+2K193385TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc.20200—
+2K191838Clearform AlignersMotor City Lab Works20203—
+2K2002143D Predict3D Smile USA, Inc.20200—
+2K192596ULab Systems Dental Aligner KitUlab Systems, Inc.20208—
+2K1921193M Clarity Aligners3M Company20193—
+2K190948Magic Clear AlignersVoodoo Manufacturing, Inc.20190—
+2K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc.201818—
+2K182826Ormco Spark Aligner SystemSybron Dental Specialties20186—
+2K180107Blue Sky Bio AlignerBlue Sky Bio, LLC20184—
+2K171674Angel Align SystemSmile Development Corp20186—
+2K132145MTM (R) Clear AlignerDentsply International, Inc.20131—
+3K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.20250—
+3K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+3K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+3K240597Tera Harz ClearGraphy, Inc.20240—
+3K231884TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd.20230—
+3K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+3K223355Tera Harz ClearGraphy, Inc.20222—
+3K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC20220—
+3K212680LuxCreo Clear Aligner SystemLuxCreo, Inc.20223—
+3K220287Invisalign SystemAlign Technology, Inc.2022131
+3K203688Clear AlignerWuxi EA Medical Instruments Technologies Limited.20213—
+3K212660Smylio Invisible Clear AlignersSmylio, Inc.20217—
+3K2106526MS Invisible AlignerSms Opco, LLC20210—
+3K210540Ohlendorf Clear AlignerOhlendorf Appliance Laboratory20211—
+3K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products20212—
+3K202792BRIUS Clear AlignersBrius Technologies, Inc.20212—
+3K203339NEOLab Clear AlignersNew England Ortho Lab, Inc.20210—
+3K202685Eon AlignerEon Dental Jordan, LLC20200—
+3K193130MVP Aligner SystemMvp Aligners, LLC20200—
+3K192069Aerodentis SystemDror Orthodesign20201—
+3K191990OSW Aligner SystemOsw Manufacturing, LLC20191—
+3K163155MTM Clear AlignerDentsply Sirona20170—
+4K253282ZSmile SystemDror Orthodesign, Ltd.20260—
+4K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+4K251758Serafin®Tns Co., Ltd.20250—
+4K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+4K251616Clear MiracleOds Co., Ltd.20250—
+4K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—
+4K250487SparkTM Clear Aligner SystemOrmco Corporation20250—
+4K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+4K233152GENIOVA alignersGeniova Technologies Sociedad Limitada20240—
+4K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.20241—
+4K241137Clear Moves AlignerClear Moves Aligners20240—
+4K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation20240—
+4K232074Serafin®Tns Co., Ltd.20241—
+4K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231—
+4K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.20233—
+4K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)3M Company, Unitek Orthodontic Products20231—
+4K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.20221—
+4K222418NuvolaGruppo Europeo Ortodonzia Srl20222—
+4K220835ArklignersArklign Laboratories20220—
+4K220726K ClearKline Europe GmbH20221—
+4K211510uLab Systems Dental Aligner KitUlab Systems, Inc.20222—
+5K260527FACE4D AlignerAvinent Implant System S.L.U.20260—
+5K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+5K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—
+5K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.20250—
+5K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.20250—
+5K242929Fas Aligner SystemXplora 3D Europe S.L20240—
+5K241412Invisalign SystemAlign Technology, Inc.20242—
+5K2332573M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products202301
+5K223141STR8 Clear AlignerStr8 Oral Care20231—
+6K252380Invisalign SystemAlign Technology, Inc.20251—
+6K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)20240—
+7K262196Invisalign SystemAlign Technology, Inc.20260—