510(k) Report

Devices descending from K101477

6 later devices reach Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.20181—
+1K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA20151—
+1K111250Dry Mouth MouthwashDr. Fresh, Inc.20122—
+2K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.20240—
+2K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral…Syendgen, Inc.20180—
+2K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath20180—