Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs

FDA 510(k) K041563 · Glaxosmithkline Consumer Healthcare, L.P.

Substantially Equivalent

510(k) numberK041563

Submission

Device name
Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs
Applicant
Glaxosmithkline Consumer Healthcare, L.P.
Parsippany, NJ, US
Received
June 10, 2004
Decision date
August 27, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFD – Saliva, Artificial
Device class
Unclassified

Other 510(k)s with product code LFD

510(k)DeviceApplicantDecision
K253778Allday Moisturizing RinseLFD · Traditional Elevate Oral Care02/27/2026SE
K250390CloSYS® Dry Mouth Sensitive Mouth RinseLFD · Traditional Rowpar Pharmaceuticals, Inc.05/19/2025SE
K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)LFD · Traditional Laclede, Inc.04/19/2024SE
K234015Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional Eusa Pharma (Uk) Limited03/11/2024SE
K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayLFD · Traditional Gurunanda, LLC08/22/2023SE
K202689Dentilube SprayLFD · Traditional Oxy2plus, LLC09/03/2021SE
K203567Oral-B Dry Mouth Oral RinseLFD · Traditional The Procter & Gamble Company04/05/2021SE
K201277Oral-B Dry Mouth Oral RinseLFD · Traditional The Procter & Gamble Company09/02/2020SE
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional Oralabs, Inc.11/21/2019SE
K190144MucoPEGLFD · Traditional Sunbio, Inc.11/05/2019SE

Questions and answers

When was Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs cleared by the FDA?

Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs (K041563) received a 510(k) decision of Substantially Equivalent on August 27, 2004, 78 days after the submission was received.

What is the product code of K041563?

The FDA product code is LFD – Saliva, Artificial, a Unclassified device.