510(k) Report

Devices descending from K180346

5 later devices reach Byte Aligner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230199Byte Aligner SystemDentsply Sirona, Inc.202301
+1K203624Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20221—
+1K212961SmilersBiotech Dental Smilers, Sas20210—
+1K191774SmileAlign Orthodontic Aligner System3D Global Biotech, Inc.20190—
+2K223454Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd.20230—