FDA 510(k) Applications for Medical Device Product Code "LFD"
(Saliva, Artificial)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K091718 | BARTOR PHARMACAL CO., INC. | NEUTRASAL | 09/02/2009 |
| K142657 | BIO COSMETICS, S.L. | XEROSTOM SALIVA SUBSTITUTE GEL | 09/14/2015 |
| K072306 | BIO-X HEALTHCARE S.A. | BIOXTRA MOISTURIZING GEL | 11/15/2007 |
| K120552 | BIOCOSMETICS LABORATORIES | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA | 06/06/2012 |
| K163029 | BIOPHARM CONSULT, L.L.C. | HydrisÖ Oral Rinse | 06/19/2017 |
| K111250 | DR. FRESH, INC. | DRY MOUTH MOUTHWASH | 04/27/2012 |
| K171542 | Dr. Harold Katz, LLC (dba TheraBreath | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | 03/16/2018 |
| K150074 | ELEVATE ORAL CARE | Elevate Moisturizing Spray | 06/19/2015 |
| K162167 | EUSA Pharma (UK) Limited | Caphosol Artifical Saliva Tablets | 03/31/2017 |
| K152406 | FORWARD SCIENCE LLC | SalivaMAX | 12/23/2015 |
| K101346 | GC AMERICA, INC. | GC ORAL MOISTURIZING GEL | 01/27/2011 |
| K981693 | GEBAUER CO. | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 | 08/06/2001 |
| K101477 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH | 09/28/2010 |
| K103745 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | 07/20/2011 |
| K123731 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | 01/04/2013 |
| K041563 | GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. | OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS | 08/27/2004 |
| K231205 | GuruNanda LLC | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | 08/22/2023 |
| K030802 | INPHARMA A.S. | CAPHOSOL | 11/25/2003 |
| K991938 | INPHARMA A.S. | CAPHOSOL ARTIFICIAL SALIVA | 08/10/1999 |
| K093642 | INVADO PHARMACEUTICALS | NEUTRASAL | 12/11/2009 |
| K142549 | J.C.E.C. Company, Inc. (doing business as Fountain Health Ca | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste | 05/26/2015 |
| K173808 | Jeffrey Ward Cash, DDS | VoutiaÖ | 07/27/2018 |
| K051812 | LABORATOIRES CARILENE S.A.S. | TGO SPRAY | 10/21/2005 |
| K061331 | LACLEDE, INC. | ORAL BALANCE LIQUID/ GEL | 07/25/2006 |
| K180680 | Laclede, Inc. | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | 10/11/2018 |
| K110116 | LORIN TECHNOLOGIES CORPORATION | XEROS DRY MOUTH PUMP | 04/08/2011 |
| K152201 | MedActive Oral Pharmaceuticals, LLC. | MedActive Oral Gel and Spray | 12/30/2015 |
| K071617 | ORAL BIOTECH | ORAL NEUTRALIZER | 10/19/2007 |
| K181839 | OraLabs, Inc. | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | 11/21/2019 |
| K202689 | Oxy2plus, LLC | Dentilube Spray | 09/03/2021 |
| K062653 | PARNELL PHARMACEUTICALS, INC. | MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 | 10/27/2006 |
| K122663 | QUANTUM, INC. | ORAMOIST | 05/30/2013 |
| K024148 | SINCLAIR PHARMACEUTICALS, LTD. | SALINUM, ORCLAIR | 09/15/2003 |
| K190144 | SunBio, Inc. | MucoPEG | 11/05/2019 |
| K181134 | Sunstar Americas Inc | GòUòM HYDRAL Dry Mouth Oral Gel, GòUòM HYDRAL Dry Mouth Oral Rinse, GòUòM HYDRAL Dry Mouth Oral Spray | 07/13/2018 |
| K173237 | Syendgen, Inc. | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist | 03/19/2018 |
| K091419 | THE PROCTER & GAMBLE CO. | VICKS POWERSHOT DRY THROAT & MOUTH RELIEF | 08/28/2009 |
| K201277 | The Procter & Gamble Company | Oral-B Dry Mouth Oral Rinse | 09/02/2020 |
| K203567 | The Procter & Gamble Company | Oral-B Dry Mouth Oral Rinse | 04/05/2021 |
| K181194 | Triumph Pharmaceuticals, Inc. | SmartMouth DryMouth Oral Rinse | 02/15/2019 |
| K163476 | You First Services, Incorporated | Lubricity | 05/10/2017 |
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