510(k) Report

Devices descending from K212680

3 later devices reach LuxCreo Clear Aligner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250739Primeprint Direct AlignerDreve Dentamid GmbH20250—
+1K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+1K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.20250—