Product Code: LFD FDA unclassified

Saliva, Artificial

Unknown

Artificial saliva is a product used to relieve dry mouth (xerostomia) by substituting for or supplementing natural saliva, typically in patients with reduced salivary gland function due to disease, radiation therapy, or medication. This device is currently unclassified by the FDA, meaning it has not been formally assigned a risk class through the standard regulatory classification process. It carries product code LFD and no regulation number or medical specialty has been assigned. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LFD
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 50 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253778	Allday Moisturizing Rinse	Feb 27, 2026	Substantially Equivalent	Elevate Oral Care
K250390	CloSYS® Dry Mouth Sensitive Mouth Rinse	May 19, 2025	Substantially Equivalent	Rowpar Pharmaceuticals, Inc.
K240508	Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)	Apr 19, 2024	Substantially Equivalent	Laclede, Inc.
K234015	Caphosol® Artifical Saliva (32 doses sachet box)	Mar 11, 2024	Substantially Equivalent	Eusa Pharma (Uk) Limited
K231205	GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray	Aug 22, 2023	Substantially Equivalent	Gurunanda, LLC
K202689	Dentilube Spray	Sep 03, 2021	Substantially Equivalent	Oxy2plus, LLC
K203567	Oral-B Dry Mouth Oral Rinse	Apr 05, 2021	Substantially Equivalent	The Procter & Gamble Company
K201277	Oral-B Dry Mouth Oral Rinse	Sep 02, 2020	Substantially Equivalent	The Procter & Gamble Company
K181839	CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray	Nov 21, 2019	Substantially Equivalent	Oralabs, Inc.
K190144	MucoPEG	Nov 05, 2019	Substantially Equivalent	Sunbio, Inc.
K181194	SmartMouth DryMouth Oral Rinse	Feb 15, 2019	Substantially Equivalent	Triumph Pharmaceuticals, Inc.
K180680	Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray	Oct 11, 2018	Substantially Equivalent	Laclede, Inc.
K173808	Voutia	Jul 27, 2018	Substantially Equivalent	Jeffrey Ward Cash, Dds
K181134	GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray	Jul 13, 2018	Substantially Equivalent	Sunstar Americas, Inc.
K173237	Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist	Mar 19, 2018	Substantially Equivalent	Syendgen, Inc.
K171542	TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges	Mar 16, 2018	Substantially Equivalent	Dr. Harold Katz, LLC (Dba Therabreath
K163029	Hydris Oral Rinse	Jun 19, 2017	Substantially Equivalent	Biopharm Consult, LLC
K163476	Lubricity	May 10, 2017	Substantially Equivalent	You First Services, Incorporated
K162167	Caphosol Artifical Saliva Tablets	Mar 31, 2017	Substantially Equivalent	Eusa Pharma (Uk) Limited
K152201	MedActive Oral Gel and Spray	Dec 30, 2015	Substantially Equivalent	Medactive Oral Pharmaceuticals, LLC
K152406	SalivaMAX	Dec 23, 2015	Substantially Equivalent	Forward Science, LLC
K142657	XEROSTOM SALIVA SUBSTITUTE GEL	Sep 14, 2015	Substantially Equivalent	Bio Cosmetics, S.L.
K150074	Elevate Moisturizing Spray	Jun 19, 2015	Substantially Equivalent	Elevate Oral Care
K142549	Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste	May 26, 2015	Substantially Equivalent	J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA
K122663	ORAMOIST	May 30, 2013	Substantially Equivalent	Quantum, Inc.
K123731	BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY	Jan 04, 2013	Substantially Equivalent	Glaxosmithkline Consumer Healthcare (Gskch)
K120552	AIR LIFT/XEROSTOM ARTIFICIAL SALIVA	Jun 06, 2012	Substantially Equivalent	Biocosmetics Laboratories
K111250	DRY MOUTH MOUTHWASH	Apr 27, 2012	Substantially Equivalent	Dr. Fresh, Inc.
K103745	BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF	Jul 20, 2011	Substantially Equivalent	Glaxosmithkline Consumer Healthcare (Gskch)
K110116	XEROS DRY MOUTH PUMP	Apr 08, 2011	Substantially Equivalent	Lorin Technologies Corporation
K101346	GC ORAL MOISTURIZING GEL	Jan 27, 2011	Substantially Equivalent	GC America, Inc.
K101477	BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH	Sep 28, 2010	Substantially Equivalent	Glaxosmithkline Consumer Healthcare (Gskch)
K093642	NEUTRASAL	Dec 11, 2009	Substantially Equivalent	Invado Pharmaceuticals
K091718	NEUTRASAL	Sep 02, 2009	Substantially Equivalent	Bartor Pharmacal Co., Inc.
K091419	VICKS POWERSHOT DRY THROAT & MOUTH RELIEF	Aug 28, 2009	Substantially Equivalent	The Procter & Gamble Co.
K072306	BIOXTRA MOISTURIZING GEL	Nov 15, 2007	Substantially Equivalent	Bio-X Healthcare S.A.
K071617	ORAL NEUTRALIZER	Oct 19, 2007	Substantially Equivalent	Oral Biotech
K062653	MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098	Oct 27, 2006	Substantially Equivalent	Parnell Pharmaceuticals, Inc.
K061331	ORAL BALANCE LIQUID/ GEL	Jul 25, 2006	Substantially Equivalent	Laclede, Inc.
K051812	TGO SPRAY	Oct 21, 2005	Substantially Equivalent	Laboratoires Carilene S.A.S.
K041563	OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS	Aug 27, 2004	Substantially Equivalent	Glaxosmithkline Consumer Healthcare, L.P.
K030802	CAPHOSOL	Nov 25, 2003	Substantially Equivalent	Inpharma A.S.
K024148	SALINUM, ORCLAIR	Sep 15, 2003	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K981693	SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25	Aug 06, 2001	Substantially Equivalent	Gebauer Co.
K991938	CAPHOSOL ARTIFICIAL SALIVA	Aug 10, 1999	Substantially Equivalent	Inpharma A.S.
K874106	GLANDOSANE (SALIVART) SYNTHETIC SALIVA	Apr 15, 1988	Substantially Equivalent	Fresenius USA, Inc.
K851026	MOI-STIR ORAL SWABSTICK(S)	May 21, 1985	Substantially Equivalent	Kingswood Laboratories, Inc.
K840807	THROAT MOI-STIR	May 25, 1984	Substantially Equivalent	Kingswood Laboratories, Inc.
K822971	SALIVA SUBSTITUTE	Nov 16, 1982	Substantially Equivalent	Roxane Laboratories, Inc.
K810157	MOI-STIR	Feb 10, 1981	Substantially Equivalent	Kingswood Laboratories, Inc.