510(k) Report

Devices descending from K780619

136 later devices reach Preformed Tooth Positioner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981095Align SystemAlign Technology1998135—
+2K183229Argen Clear AlignerArgen Corporation20193—
+2K123514Clearpath AlignerQserve America, Inc.20136—
+2K123925MTM Clear Aligner in-OfficeDentsply International, Inc.20132—
+2K073121Nubrace Invisible Removable OrthodonticsNubrace, Inc.20097—
+2K082556ClearcorrectClearcorrect, Inc.200964—
+2K081960Invisalign SystemAlign Technology200882—
+2K080246Composite Aligner ButtonDentsply Interntional20080—
+2K071970Clear Image AlignerSpecialty Appliance Works, Inc.200767—
+2K062828Mouthguard and Aligner MaterialsDentsply Intl., Inc.20066—
+3K222619EnsmileEnsmile Pvt, Ltd.20231—
+3K200908iSMILE3D Diagnostix, Inc.20202—
+3K200125Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH20201—
+3K192846Argen Clear Aligner, Argen Clear Aligner PremiumArgen Corporation20202—
+3K191823Clear-AlignersCdb Corporation20191—
+3K182388Krystal Klear AlignersShatkin F.I.R.S.T., LLC20190—
+3K190583DynaFlexDyna Flex20190—
+3K1831593M Clarity Aligners3M Company20184—
+3K180241Orthocaps TwinalignerOrtho Caps GmbH201815—
+3K162609ClearPath AlignerClearpath Orthodontics, Ltd.20174—
+3K163155MTM Clear AlignerDentsply Sirona20170—
+3K1636893M Clear Tray Aligner3M Unitek Corporation201713—
+3K151965Dentti SystemMartz, Inc.20160—
+3K143630Invisalign SystemAlign Technology, Inc.201541—
+3K143499eClignerEclear International Co., Ltd.20151—
+3K134015M-PM-DiscMerz Dental GmbH20141—
+3K132145MTM (R) Clear AlignerDentsply International, Inc.20131—
+3K121396DynaflexDyna Flex20120—
+3K113618Clearcorrect SystemClearcorrect, Inc.201260—
+3K072522Thermoform Sheet Materials and AccessoriesDentsply International, Inc.20073—
+4K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…Bernhard Förster GmbH20240—
+4K233544MesheetDentis Co., Ltd.20240—
+4K221537Nightwear AlignersSmylio, Inc.20230—
+4K223338Toothsi, SmilealignersMakeo Healthcare Technologies Private Limited20230—
+4K222308Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd.20220—
+4K211427CREOKORREKT AlignersCreodent Prosthetics, Ltd.20220—
+4K220140ClearCorrect SystemClearcorrect, LLC20220—
+4K212680LuxCreo Clear Aligner SystemLuxCreo, Inc.20223—
+4K210763Inman Digital Clear AlignersInman Orthodontic Laboratories, Inc.20210—
+4K210320ClearCorrect SystemClearcorrect, LLC20210—
+4K193622TRIOCLEAR SystemPerfection Aligner System Hong Kong Limited20211—
+4K210613HIT Clear AlignerCdb Corporation20210—
+4K203737Spark Clear Aligner SystemOrmco Corporation202110—
+4K201104AsoAlignerAso International Manila, Inc.20210—
+4K173738ArchworxUtah Medical Products and Services20210—
+4K202857ClearPath AlignerClearpath Orthodontics, Ltd.20213—
+4K193385TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc.20200—
+4K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+4K191838Clearform AlignersMotor City Lab Works20203—
+4K192338NEOLab Clear AlignersNew England Ortho Lab, Inc.20200—
+4K2002143D Predict3D Smile USA, Inc.20200—
+4K192596ULab Systems Dental Aligner KitUlab Systems, Inc.20208—
+4K191837UniSmile Clear Aligner SystemVitang Technology, LLC20200—
+4K191836Ceramill A-SplintAmann Girrbach AG20190—
+4K1921193M Clarity Aligners3M Company20193—
+4K190948Magic Clear AlignersVoodoo Manufacturing, Inc.20190—
+4K180346Byte Aligner SystemStraight Smile, LLC20195—
+4K180648Park Dental Research AlignersPark Dental Research Corporation20190—
+4K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care20183—
+4K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc.201818—
+4K182826Ormco Spark Aligner SystemSybron Dental Specialties20186—
+4K172765Smart Moves CompleteGreat Lakes Orthodontics, Ltd.20183—
+4K173785Custom Clear Aligner SystemDerby Dental Laboratory20185—
+4K180107Blue Sky Bio AlignerBlue Sky Bio, LLC20184—
+4K171674Angel Align SystemSmile Development Corp20186—
+4K171860Sureclear alignersEmergo Global Consulting, LLC20180—
+5K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+5K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+5K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.20250—
+5K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—
+5K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+5K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+5K240597Tera Harz ClearGraphy, Inc.20240—
+5K230199Byte Aligner SystemDentsply Sirona, Inc.202301
+5K231884TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd.20230—
+5K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+5K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—
+5K223355Tera Harz ClearGraphy, Inc.20222—
+5K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC20220—
+5K221097SmileSeriesOrdont Orthodontic Laboratories, Inc.20221—
+5K203624Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20221—
+5K212803DailyMate Orthodontic Aligner System3D Global Biotech, Inc.20222—
+5K220287Invisalign SystemAlign Technology, Inc.2022131
+5K213297RedlineJohns Dental Laboratories20220—
+5K212496Ortho Aligner SystemOrtho Lab Services, LLC20210—
+5K211537QuickAlignersOral Image, Inc.20210—
+5K203688Clear AlignerWuxi EA Medical Instruments Technologies Limited.20213—
+5K212660Smylio Invisible Clear AlignersSmylio, Inc.20217—
+5K212961SmilersBiotech Dental Smilers, Sas20210—
+5K2106526MS Invisible AlignerSms Opco, LLC20210—
+5K210540Ohlendorf Clear AlignerOhlendorf Appliance Laboratory20211—
+5K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products20212—
+5K202792BRIUS Clear AlignersBrius Technologies, Inc.20212—
+5K203339NEOLab Clear AlignersNew England Ortho Lab, Inc.20210—
+5K200005Concinnity AlignersDrake Precision Dental Laboratory, Inc.20200—
+5K202685Eon AlignerEon Dental Jordan, LLC20200—
+5K193130MVP Aligner SystemMvp Aligners, LLC20200—
+5K192069Aerodentis SystemDror Orthodesign20201—
+5K191308U-AlignerUniversal Orthodontic Laboratory, Inc.20200—
+5K190394SunClear Aligner systemSun Dental Laboratories, LLC20190—