510(k) Report

Devices descending from K040874

68 later devices reach Red, White & Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121396DynaflexDyna Flex20120—
+1K071970Clear Image AlignerSpecialty Appliance Works, Inc.200767—
+2K182388Krystal Klear AlignersShatkin F.I.R.S.T., LLC20190—
+2K190583DynaFlexDyna Flex20190—
+2K151965Dentti SystemMartz, Inc.20160—
+2K082556ClearcorrectClearcorrect, Inc.200964—
+3K191823Clear-AlignersCdb Corporation20191—
+3K113618Clearcorrect SystemClearcorrect, Inc.201260—
+4K223338Toothsi, SmilealignersMakeo Healthcare Technologies Private Limited20230—
+4K212680LuxCreo Clear Aligner SystemLuxCreo, Inc.20223—
+4K210763Inman Digital Clear AlignersInman Orthodontic Laboratories, Inc.20210—
+4K210320ClearCorrect SystemClearcorrect, LLC20210—
+4K210613HIT Clear AlignerCdb Corporation20210—
+4K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+4K192338NEOLab Clear AlignersNew England Ortho Lab, Inc.20200—
+4K191837UniSmile Clear Aligner SystemVitang Technology, LLC20200—
+4K180346Byte Aligner SystemStraight Smile, LLC20195—
+4K180648Park Dental Research AlignersPark Dental Research Corporation20190—
+4K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care20183—
+4K180241Orthocaps TwinalignerOrtho Caps GmbH201815—
+4K172765Smart Moves CompleteGreat Lakes Orthodontics, Ltd.20183—
+4K173785Custom Clear Aligner SystemDerby Dental Laboratory20185—
+4K171860Sureclear alignersEmergo Global Consulting, LLC20180—
+4K1636893M Clear Tray Aligner3M Unitek Corporation201713—
+5K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+5K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+5K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—
+5K230199Byte Aligner SystemDentsply Sirona, Inc.202301
+5K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—
+5K203624Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20221—
+5K212803DailyMate Orthodontic Aligner System3D Global Biotech, Inc.20222—
+5K213297RedlineJohns Dental Laboratories20220—
+5K212496Ortho Aligner SystemOrtho Lab Services, LLC20210—
+5K212961SmilersBiotech Dental Smilers, Sas20210—
+5K193622TRIOCLEAR SystemPerfection Aligner System Hong Kong Limited20211—
+5K193385TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc.20200—
+5K200005Concinnity AlignersDrake Precision Dental Laboratory, Inc.20200—
+5K191308U-AlignerUniversal Orthodontic Laboratory, Inc.20200—
+5K191838Clearform AlignersMotor City Lab Works20203—
+5K2002143D Predict3D Smile USA, Inc.20200—
+5K192596ULab Systems Dental Aligner KitUlab Systems, Inc.20208—
+5K190394SunClear Aligner systemSun Dental Laboratories, LLC20190—
+5K191774SmileAlign Orthodontic Aligner System3D Global Biotech, Inc.20190—
+5K182658BiolinerFive Star Orthodontic Lab & Supply20190—
+5K190948Magic Clear AlignersVoodoo Manufacturing, Inc.20190—
+5K183643Clear Image AlignersSpecialty Appliance Works, Inc.20191—
+5K1831593M Clarity Aligners3M Company20184—
+5K180107Blue Sky Bio AlignerBlue Sky Bio, LLC20184—
+6K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.20250—
+6K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.20241—
+6K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+6K240597Tera Harz ClearGraphy, Inc.20240—
+6K231884TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd.20230—
+6K223454Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20230—
+6K223355Tera Harz ClearGraphy, Inc.20222—
+6K221475MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC20220—
+6K202792BRIUS Clear AlignersBrius Technologies, Inc.20212—
+6K192470DenMat Orthodontic AlignersDenmat Holdings, LLC20190—
+6K1921193M Clarity Aligners3M Company20193—
+7K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—
+7K251616Clear MiracleOds Co., Ltd.20250—
+7K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+7K233152GENIOVA alignersGeniova Technologies Sociedad Limitada20240—
+7K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation20240—
+7K220835ArklignersArklign Laboratories20220—
+7K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products20212—
+8K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)3M Company, Unitek Orthodontic Products20231—
+9K2332573M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products202301