510(k) Report

Devices descending from K062653

3 later devices reach Mouthkote Oral Moisturizer, Model 50930-098 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072306Bioxtra Moisturizing GelBio-X Healthcare S.A.20072—
+2K202689Dentilube SprayOxy2plus, LLC20210—
+2K101346GC Oral Moisturizing GelGC America, Inc.20110—