Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray

Q: What is the product code of K123731?

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

FDA 510(k) K123731 · Glaxosmithkline Consumer Healthcare (Gskch)

Substantially Equivalent

510(k) numberK123731

Submission

Device name: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray
Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
Parsippany, NJ, US
Received: December 5, 2012
Decision date: January 4, 2013
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement 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)	Device	Applicant	Decision
K253778	Allday Moisturizing RinseLFD · Traditional	Elevate Oral Care	02/27/2026SE
K250390	CloSYS® Dry Mouth Sensitive Mouth RinseLFD · Traditional	Rowpar Pharmaceuticals, Inc.	05/19/2025SE
K240508	Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)LFD · Traditional	Laclede, Inc.	04/19/2024SE
K234015	Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional	Eusa Pharma (Uk) Limited	03/11/2024SE
K231205	GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayLFD · Traditional	Gurunanda, LLC	08/22/2023SE
K202689	Dentilube SprayLFD · Traditional	Oxy2plus, LLC	09/03/2021SE
K203567	Oral-B Dry Mouth Oral RinseLFD · Traditional	The Procter & Gamble Company	04/05/2021SE
K201277	Oral-B Dry Mouth Oral RinseLFD · Traditional	The Procter & Gamble Company	09/02/2020SE
K181839	CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional	Oralabs, Inc.	11/21/2019SE
K190144	MucoPEGLFD · Traditional	Sunbio, Inc.	11/05/2019SE

More from Sunbio, Inc.

510(k)	Device	Decision
K103745	Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefLFD · Traditional	07/20/2011SE
K101477	Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashLFD · Traditional	09/28/2010SE

Questions and answers

When was Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray cleared by the FDA?

Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray (K123731) received a 510(k) decision of Substantially Equivalent on January 4, 2013, 30 days after the submission was received.

What is the product code of K123731?

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