510(k) Report

Devices descending from K113618

60 later devices reach Clearcorrect System through their predicates, nearest generation first.

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