510(k) Report

Devices descending from K163689

13 later devices reach 3M Clear Tray Aligner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193622TRIOCLEAR SystemPerfection Aligner System Hong Kong Limited20211—
+1K193385TP Orthodontics Clear Aligner SystemTp Orthodontics, Inc.20200—
+1K1831593M Clarity Aligners3M Company20184—
+1K180107Blue Sky Bio AlignerBlue Sky Bio, LLC20184—
+2K240597Tera Harz ClearGraphy, Inc.20240—
+2K231884TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd.20230—
+2K223355Tera Harz ClearGraphy, Inc.20222—
+2K1921193M Clarity Aligners3M Company20193—
+3K251616Clear MiracleOds Co., Ltd.20250—
+3K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation20240—
+3K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)3M Company, Unitek Orthodontic Products20212—
+4K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)3M Company, Unitek Orthodontic Products20231—
+5K2332573M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products202301