510(k) Report

Devices descending from K073045

10 later devices reach Sapphire Ceramic Bracket through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190608Mei Ceramic BracketOrthosun Co., Ltd.20190—
+1K163117Alpha PureKoroad America20171—
+1K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd.20160—
+1K150141Orthodontics BracketSpeed Dental Co., Ltd.20152—
+1K102561Orthodontic Ceramic BracketHt Co., Ltd.20110—
+1K101481Biomers Translucent Orthodontic BracketBiomers Products, LLC20100—
+1K090567Orthodontic Ceramic BracketStar Dentech Korea., Corp20092—
+2K201038Luce Ceramic BracketLuce Castle Co., Ltd.20200—
+2K182672ROSA BracketGni Co., Ltd.20191—
+3K201410VENUS Bracket, ROSE BracketGni Co., Ltd.20210—