510(k) Report

Devices descending from K091020

11 later devices reach Bluephase 20I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163613Bluephase Style 20iIvoclar Vivadent, AG20179—
+1K131906Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen…Satelec - Acteon Group20140—
+2K190272Bluephase PowerCureIvoclar Vivadent, AG20198—
+3K200809D-LUX+DiaDent Group International20207—
+4K242386BluemoonGenoss Co., Ltd.20250—
+4K223414Curing Light, Model: MaxCure 9Guilin Refine Medical Instrument Co., Ltd.20230—
+4K220826LED Curing LightFoshan Coxo Medical Instrument Co., Ltd.20222—
+4K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd.20221—
+5K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.20260—
+5K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.20250—
+5K232076FibercureLumendo AG20230—