510(k) Report

Devices descending from K180107

4 later devices reach Blue Sky Bio Aligner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240597Tera Harz ClearGraphy, Inc.20240—
+1K223355Tera Harz ClearGraphy, Inc.20222—
+2K251616Clear MiracleOds Co., Ltd.20250—
+2K233935DigiLine Direct Print Aligner SystemPark Dental Research Corporation20240—