Product code LFD · Class U
Saliva, Artificial
1510(k)s in 12 months (50 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in LFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Kingswood Laboratories, Inc. | 3 | 1 |
| Gebauer Co. | 1 | 2 |
| Glaxosmithkline Consumer Healthcare (Gskch) | 3 | 0 |
| Laclede, Inc. | 3 | 0 |
| The Procter & Gamble Co. | 3 | 0 |
| Elevate Oral Care | 2 | 0 |
| Eusa Pharma (Uk) Limited | 2 | 0 |
| Inpharma A.S. | 2 | 0 |
| Sunstar Americas, Inc. | 1 | 1 |
| Bartor Pharmacal Co., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2026 | K253778 | Allday Moisturizing Rinse Elevate Oral Care | LFD |
| May 19, 2025 | K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse Rowpar Pharmaceuticals, Inc. | LFD |
| Apr 19, 2024 | K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) Laclede, Inc. | LFD |
| Mar 11, 2024 | K234015 | Caphosol® Artifical Saliva (32 doses sachet box) Eusa Pharma (Uk) Limited, GB | LFD |
| Aug 22, 2023 | K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray Gurunanda, LLC | LFD |
| Sep 3, 2021 | K202689 | Dentilube Spray Oxy2plus, LLC | LFD |
| Apr 5, 2021 | K203567 | Oral-B Dry Mouth Oral Rinse The Procter & Gamble Company | LFD |
| Sep 2, 2020 | K201277 | Oral-B Dry Mouth Oral Rinse The Procter & Gamble Company | LFD |
| Nov 21, 2019 | K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray Oralabs, Inc. | LFD |
| Nov 5, 2019 | K190144 | MucoPEG Sunbio, Inc., KR | LFD |
| Feb 15, 2019 | K181194 | SmartMouth DryMouth Oral Rinse Triumph Pharmaceuticals, Inc. | LFD |
| Oct 11, 2018 | K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray Laclede, Inc. | LFD |
| Jul 27, 2018 | K173808 | Voutia Jeffrey Ward Cash, Dds | LFD |
| Jul 13, 2018 | K181134 | GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray Sunstar Americas, Inc. | LFD |
| Mar 19, 2018 | K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mi Syendgen, Inc. | LFD |
| Mar 16, 2018 | K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges Dr. Harold Katz, LLC (Dba Therabreath | LFD |
| Jun 19, 2017 | K163029 | Hydris Oral Rinse Biopharm Consult, LLC | LFD |
| May 10, 2017 | K163476 | Lubricity You First Services, Incorporated | LFD |
| Mar 31, 2017 | K162167 | Caphosol Artifical Saliva Tablets Eusa Pharma (Uk) Limited, GB | LFD |
| Dec 30, 2015 | K152201 | MedActive Oral Gel and Spray Medactive Oral Pharmaceuticals, LLC | LFD |
| Dec 23, 2015 | K152406 | SalivaMAX Forward Science, LLC | LFD |
| Sep 14, 2015 | K142657 | XEROSTOM SALIVA SUBSTITUTE GEL Bio Cosmetics, S.L., ES | LFD |
| Jun 19, 2015 | K150074 | Elevate Moisturizing Spray Elevate Oral Care | LFD |
| May 26, 2015 | K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | LFD |
| May 30, 2013 | K122663 | ORAMOIST Quantum, Inc. | LFD |
| Jan 4, 2013 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY Glaxosmithkline Consumer Healthcare (Gskch) | LFD |
| Jun 6, 2012 | K120552 | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA Biocosmetics Laboratories | LFD |
| Apr 27, 2012 | K111250 | DRY MOUTH MOUTHWASH Dr. Fresh, Inc. | LFD |
| Jul 20, 2011 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF Glaxosmithkline Consumer Healthcare (Gskch) | LFD |
| Apr 8, 2011 | K110116 | XEROS DRY MOUTH PUMP Lorin Technologies Corporation | LFD |
| Jan 27, 2011 | K101346 | GC ORAL MOISTURIZING GEL GC America, Inc. | LFD |
| Sep 28, 2010 | K101477 | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH Glaxosmithkline Consumer Healthcare (Gskch) | LFD |
| Dec 11, 2009 | K093642 | NEUTRASAL Invado Pharmaceuticals | LFD |
| Sep 2, 2009 | K091718 | NEUTRASAL Bartor Pharmacal Co., Inc. | LFD |
| Aug 28, 2009 | K091419 | VICKS POWERSHOT DRY THROAT & MOUTH RELIEF The Procter & Gamble Co. | LFD |
| Nov 15, 2007 | K072306 | BIOXTRA MOISTURIZING GEL Bio-X Healthcare S.A. | LFD |
| Oct 19, 2007 | K071617 | ORAL NEUTRALIZER Oral Biotech | LFD |
| Oct 27, 2006 | K062653 | MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 Parnell Pharmaceuticals, Inc. | LFD |
| Jul 25, 2006 | K061331 | ORAL BALANCE LIQUID/ GEL Laclede, Inc. | LFD |
| Oct 21, 2005 | K051812 | TGO SPRAY Laboratoires Carilene S.A.S. | LFD |
| Aug 27, 2004 | K041563 | OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS Glaxosmithkline Consumer Healthcare, L.P. | LFD |
| Nov 25, 2003 | K030802 | CAPHOSOL Inpharma A.S. | LFD |
| Sep 15, 2003 | K024148 | SALINUM, ORCLAIR Sinclair Pharmaceuticals, Ltd., GB | LFD |
| Aug 6, 2001 | K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 Gebauer Co. | LFD |
| Aug 10, 1999 | K991938 | CAPHOSOL ARTIFICIAL SALIVA Inpharma A.S. | LFD |
| Apr 15, 1988 | K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA Fresenius USA, Inc., DE | LFD |
| May 21, 1985 | K851026 | MOI-STIR ORAL SWABSTICK(S) Kingswood Laboratories, Inc. | LFD |
| May 25, 1984 | K840807 | THROAT MOI-STIR Kingswood Laboratories, Inc. | LFD |
| Nov 16, 1982 | K822971 | SALIVA SUBSTITUTE Roxane Laboratories, Inc. | LFD |
| Feb 10, 1981 | K810157 | MOI-STIR Kingswood Laboratories, Inc. | LFD |
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