FDA.reportPublic FDA data

510(k) K041563

Device
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
510(k) number
K041563
Product code
LFD  
Decision
Substantially Equivalent (SESE)
Decision date
2004-08-27
Date received
2004-06-10
Regulation
510(k) Premarket Notification
Classification name
Saliva, Artificial
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANTHONY G AMITRANO
Address
1500 Littleton Rd. Parsippany NJ US 07054 07054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253778Allday Moisturizing RinseElevate Oral Care2026-02-27
K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.2025-05-19
K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.2024-04-19
K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited2024-03-11
K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC2023-08-22
K202689Dentilube SprayOxy2plus, LLC2021-09-03
K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company2021-04-05
K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company2020-09-02
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOralabs, Inc.2019-11-21
K190144MucoPEGSunbio, Inc.2019-11-05
K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.2019-02-15
K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.2018-10-11
K173808Voutia™Jeffrey Ward Cash, Dds2018-07-27
K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc.2018-07-13
K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistSyendgen, Inc.2018-03-19

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases