Atlas FDA

LFD

50 FDA 510(k) clearances · Product code

123 daysmedian time to decision
353 days90th percentile
50clearances measured

FDA profile

Official device name
Saliva, Artificial
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2017: 51 · 2018: 37 · 2019: 40 · 2020: 34 · 2021: 30 · 2022: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Allday Moisturizing Rinse (K253778)Elevate Oral Care2026-02-27
CloSYS® Dry Mouth Sensitive Mouth Rinse (K250390)Rowpar Pharmaceuticals, Inc.2025-05-19
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (K240508)Laclede, Inc.2024-04-19
Caphosol® Artifical Saliva (32 doses sachet box) (K234015)Eusa Pharma (Uk) Limited2024-03-11
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (K231205)Gurunanda, LLC2023-08-22
Dentilube Spray (K202689)Oxy2plus, LLC2021-09-03
Oral-B Dry Mouth Oral Rinse (K203567)The Procter & Gamble Company2021-04-05
Oral-B Dry Mouth Oral Rinse (K201277)The Procter & Gamble Company2020-09-02
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839)Oralabs, Inc.2019-11-21
MucoPEG (K190144)Sunbio, Inc.2019-11-05
SmartMouth DryMouth Oral Rinse (K181194)Triumph Pharmaceuticals, Inc.2019-02-15
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (K180680)Laclede, Inc.2018-10-11
Voutia™ (K173808)Jeffrey Ward Cash, Dds2018-07-27
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (K181134)Sunstar Americas, Inc.2018-07-13
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist (K173237)Syendgen, Inc.2018-03-19
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (K171542)Dr. Harold Katz, LLC (Dba Therabreath2018-03-16
Hydris™ Oral Rinse (K163029)Biopharm Consult, LLC2017-06-19
Lubricity (K163476)You First Services, Incorporated2017-05-10
Caphosol Artifical Saliva Tablets (K162167)Eusa Pharma (Uk) Limited2017-03-31
MedActive Oral Gel and Spray (K152201)Medactive Oral Pharmaceuticals, LLC2015-12-30
SalivaMAX (K152406)Forward Science, LLC2015-12-23
XEROSTOM SALIVA SUBSTITUTE GEL (K142657)Bio Cosmetics, S.L.2015-09-14
Elevate Moisturizing Spray (K150074)Elevate Oral Care2015-06-19
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste (K142549)J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA2015-05-26
ORAMOIST (K122663)Quantum, Inc.2013-05-30
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY (K123731)Glaxosmithkline Consumer Healthcare (Gskch)2013-01-04
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA (K120552)Biocosmetics Laboratories2012-06-06
DRY MOUTH MOUTHWASH (K111250)Dr. Fresh, Inc.2012-04-27
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF (K103745)Glaxosmithkline Consumer Healthcare (Gskch)2011-07-20
XEROS DRY MOUTH PUMP (K110116)Lorin Technologies Corporation2011-04-08
GC ORAL MOISTURIZING GEL (K101346)GC America, Inc.2011-01-27
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH (K101477)Glaxosmithkline Consumer Healthcare (Gskch)2010-09-28
NEUTRASAL (K093642)Invado Pharmaceuticals2009-12-11
NEUTRASAL (K091718)Bartor Pharmacal Co., Inc.2009-09-02
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF (K091419)The Procter & Gamble Co.2009-08-28
BIOXTRA MOISTURIZING GEL (K072306)Bio-X Healthcare S.A.2007-11-15
ORAL NEUTRALIZER (K071617)Oral Biotech2007-10-19
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 (K062653)Parnell Pharmaceuticals, Inc.2006-10-27
ORAL BALANCE LIQUID/ GEL (K061331)Laclede, Inc.2006-07-25
TGO SPRAY (K051812)Laboratoires Carilene S.A.S.2005-10-21
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS (K041563)Glaxosmithkline Consumer Healthcare, L.P.2004-08-27
CAPHOSOL (K030802)Inpharma A.S.2003-11-25
SALINUM, ORCLAIR (K024148)Sinclair Pharmaceuticals, Ltd.2003-09-15
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 (K981693)Gebauer Co.2001-08-06
CAPHOSOL ARTIFICIAL SALIVA (K991938)Inpharma A.S.1999-08-10
GLANDOSANE (SALIVART) SYNTHETIC SALIVA (K874106)Fresenius USA, Inc.1988-04-15
MOI-STIR ORAL SWABSTICK(S) (K851026)Kingswood Laboratories, Inc.1985-05-21
THROAT MOI-STIR (K840807)Kingswood Laboratories, Inc.1984-05-25
SALIVA SUBSTITUTE (K822971)Roxane Laboratories, Inc.1982-11-16
MOI-STIR (K810157)Kingswood Laboratories, Inc.1981-02-10

Track LFD automatically

Every clearance here is in the API, with alerts when new ones post.