510(k) Report

Devices descending from K992985

3 later devices reach Gluma Comfort Bond through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043562BC PlusVericom Co., Ltd.20052—
+2K192392DiaPlusDiaDent Group International20201—
+3K210421Diafil & Diafil CapsuleDiaDent Group International20210—