510(k) Report

Devices descending from K981095

135 later devices reach Align System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191990OSW Aligner SystemOsw Manufacturing, LLC20191—
+4K182658BiolinerFive Star Orthodontic Lab & Supply20190—
+4K183643Clear Image AlignersSpecialty Appliance Works, Inc.20191—
+5K253282ZSmile SystemDror Orthodesign, Ltd.20260—
+5K251758Serafin®Tns Co., Ltd.20250—
+5K251616Clear MiracleOds Co., Ltd.20250—
+5K250487SparkTM Clear Aligner SystemOrmco Corporation20250—
+5K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+5K233152GENIOVA alignersGeniova Technologies Sociedad Limitada20240—
+5K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.20241—
+5K241137Clear Moves AlignerClear Moves Aligners20240—
+5K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation20240—
+5K232074Serafin®Tns Co., Ltd.20241—
+5K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231—
+5K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.20233—
+5K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)3M Company, Unitek Orthodontic Products20231—
+5K223454Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20230—
+5K222894Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc.20221—
+5K222418NuvolaGruppo Europeo Ortodonzia Srl20222—
+5K220835ArklignersArklign Laboratories20220—
+5K220726K ClearKline Europe GmbH20221—
+5K211510uLab Systems Dental Aligner KitUlab Systems, Inc.20222—
+5K192470DenMat Orthodontic AlignersDenmat Holdings, LLC20190—
+6K260527FACE4D AlignerAvinent Implant System S.L.U.20260—
+6K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+6K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—
+6K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.20250—
+6K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.20250—
+6K242929Fas Aligner SystemXplora 3D Europe S.L20240—
+6K241412Invisalign SystemAlign Technology, Inc.20242—
+6K2332573M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products202301
+6K223141STR8 Clear AlignerStr8 Oral Care20231—
+7K252380Invisalign SystemAlign Technology, Inc.20251—
+7K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)20240—
+8K262196Invisalign SystemAlign Technology, Inc.20260—