510(k) Report

Devices descending from K874106

28 later devices reach Glandosane (Salivart) Synthetic Saliva through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991938Caphosol Artificial SalivaInpharma A.S.199927—
+2K093642NeutrasalInvado Pharmaceuticals20091—
+2K091718NeutrasalBartor Pharmacal Co., Inc.20092—
+2K071617Oral NeutralizerOral Biotech20070—
+2K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc.20063—
+2K061331Oral Balance Liquid/ GelLaclede, Inc.200613—
+2K030802CaphosolInpharma A.S.200322—
+2K024148Salinum, OrclairSinclair Pharmaceuticals, Ltd.200319—
+2K023046SST Saliva Supporting TabletsSinclair Pharmaceuticals, Ltd.20021—
+3K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.20240—
+3K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited202401
+3K163476LubricityYou First Services, Incorporated20170—
+3K162167Caphosol Artifical Saliva TabletsEusa Pharma (Uk) Limited20170—
+3K152406SalivaMAXForward Science, LLC20150—
+3K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA20151—
+3K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch)20112—
+3K101346GC Oral Moisturizing GelGC America, Inc.20110—
+3K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch)20106—
+3K072306Bioxtra Moisturizing GelBio-X Healthcare S.A.20072—
+3K051812Tgo SprayLaboratoires Carilene S.A.S.200516—
+3K041563Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsGlaxosmithkline Consumer Healthcare, L.P.20040—
+4K202689Dentilube SprayOxy2plus, LLC20210—
+4K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.20181—
+4K111250Dry Mouth MouthwashDr. Fresh, Inc.20122—
+4K110116Xeros Dry Mouth PumpLorin Technologies Corporation20111—
+5K173808Voutia™Jeffrey Ward Cash, Dds20180—
+5K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral…Syendgen, Inc.20180—
+5K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath20180—