510(k) Report

Devices descending from K123731

14 later devices reach Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.20250—
+1K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.20240—
+1K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC20230—
+1K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOralabs, Inc.20190—
+1K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.20190—
+1K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry…Sunstar Americas, Inc.201821
+1K163029Hydris™ Oral RinseBiopharm Consult, LLC20172—
+1K152201MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC20151—
+1K150074Elevate Moisturizing SprayElevate Oral Care20151—
+2K253778Allday Moisturizing RinseElevate Oral Care20260—
+2K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company20201—
+2K190144MucoPEGSunbio, Inc.20190—
+2K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath20180—
+3K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company20210—