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LFD — Saliva, Artificial Class U

FDA Device Classification

Classification Details

Product Code
LFD
Device Class
Class U
Regulation Number
Submission Type
Review Panel
DE
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253778elevate oral careAllday Moisturizing RinseFebruary 27, 2026
K250390rowpar pharmaceuticalsCloSYS® Dry Mouth Sensitive Mouth RinseMay 19, 2025
K240508lacledeSalivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)April 19, 2024
K234015eusa pharma (uk) limitedCaphosol® Artifical Saliva (32 doses sachet box)March 11, 2024
K231205gurunandaGuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayAugust 22, 2023
K202689oxy2plusDentilube SpraySeptember 3, 2021
K203567procter and gambleOral-B Dry Mouth Oral RinseApril 5, 2021
K201277procter and gambleOral-B Dry Mouth Oral RinseSeptember 2, 2020
K181839oralabsCVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayNovember 21, 2019
K190144sunbioMucoPEGNovember 5, 2019
K181194triumph pharmaceuticalsSmartMouth DryMouth Oral RinseFebruary 15, 2019
K180680lacledeSalivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayOctober 11, 2018
K173808jeffrey ward cash, ddsVoutia™July 27, 2018
K181134sunstar americasG•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRALJuly 13, 2018
K173237syendgenMoisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth OMarch 19, 2018
K171542harold katz, llc (dba therabreathTheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesMarch 16, 2018
K163029biopharm consultHydris™ Oral RinseJune 19, 2017
K163476you first services, incorporatedLubricityMay 10, 2017
K162167eusa pharma (uk) limitedCaphosol Artifical Saliva TabletsMarch 31, 2017
K152201medactive oral pharmaceuticalsMedActive Oral Gel and SprayDecember 30, 2015