510(k) Report

Devices descending from K061331

13 later devices reach Oral Balance Liquid/ Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.20240—
+1K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA20151—
+1K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch)20112—
+1K101346GC Oral Moisturizing GelGC America, Inc.20110—
+1K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch)20106—
+1K072306Bioxtra Moisturizing GelBio-X Healthcare S.A.20072—
+1K071617Oral NeutralizerOral Biotech20070—
+1K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc.20063—
+2K202689Dentilube SprayOxy2plus, LLC20210—
+2K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.20181—
+2K111250Dry Mouth MouthwashDr. Fresh, Inc.20122—
+3K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral…Syendgen, Inc.20180—
+3K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath20180—