FDA Product Code
FDA Product Code LFD — Clearance Directory
- Device Class
- —
- Assigned Panel
- Unknown
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 | Traditional | PDF ↗ |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. | 2025-05-19 | Traditional | PDF ↗ |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | 2024-03-11 | Traditional | PDF ↗ |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | Gurunanda, LLC | 2023-08-22 | Traditional | PDF ↗ |
| K202689 | Dentilube Spray | Oxy2plus, LLC | 2021-09-03 | Traditional | PDF ↗ |
| K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021-04-05 | Traditional | PDF ↗ |
| K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020-09-02 | Traditional | PDF ↗ |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Oralabs, Inc. | 2019-11-21 | Traditional | PDF ↗ |
| K190144 | MucoPEG | Sunbio, Inc. | 2019-11-05 | Traditional | PDF ↗ |
| K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. | 2019-02-15 | Traditional | PDF ↗ |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018-10-11 | Traditional | PDF ↗ |
| K173808 | Voutia | Jeffrey Ward Cash, Dds | 2018-07-27 | Traditional | PDF ↗ |
| K181134 | GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray | Sunstar Americas, Inc. | 2018-07-13 | Traditional | PDF ↗ |
| K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist | Syendgen, Inc. | 2018-03-19 | Traditional | PDF ↗ |
| K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 | Traditional | PDF ↗ |
| K163029 | Hydris Oral Rinse | Biopharm Consult, LLC | 2017-06-19 | Traditional | PDF ↗ |
| K163476 | Lubricity | You First Services, Incorporated | 2017-05-10 | Traditional | PDF ↗ |
| K162167 | Caphosol Artifical Saliva Tablets | Eusa Pharma (Uk) Limited | 2017-03-31 | Traditional | PDF ↗ |
| K152201 | MedActive Oral Gel and Spray | Medactive Oral Pharmaceuticals, LLC | 2015-12-30 | Traditional | PDF ↗ |
| K152406 | SalivaMAX | Forward Science, LLC | 2015-12-23 | Traditional | PDF ↗ |
| K142657 | XEROSTOM SALIVA SUBSTITUTE GEL | Bio Cosmetics, S.L. | 2015-09-14 | Traditional | PDF ↗ |
| K150074 | Elevate Moisturizing Spray | Elevate Oral Care | 2015-06-19 | Traditional | PDF ↗ |
| 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 | 2015-05-26 | Traditional | PDF ↗ |
| K122663 | ORAMOIST | Quantum, Inc. | 2013-05-30 | Traditional | PDF ↗ |
| K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | Glaxosmithkline Consumer Healthcare (Gskch) | 2013-01-04 | Special | PDF ↗ |
| K120552 | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA | Biocosmetics Laboratories | 2012-06-06 | Traditional | PDF ↗ |
| K111250 | DRY MOUTH MOUTHWASH | Dr. Fresh, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | Glaxosmithkline Consumer Healthcare (Gskch) | 2011-07-20 | Traditional | PDF ↗ |
| K110116 | XEROS DRY MOUTH PUMP | Lorin Technologies Corporation | 2011-04-08 | Traditional | PDF ↗ |
| K101346 | GC ORAL MOISTURIZING GEL | GC America, Inc. | 2011-01-27 | Traditional | PDF ↗ |
| K101477 | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH | Glaxosmithkline Consumer Healthcare (Gskch) | 2010-09-28 | Traditional | PDF ↗ |
| K093642 | NEUTRASAL | Invado Pharmaceuticals | 2009-12-11 | Special | PDF ↗ |
| K091718 | NEUTRASAL | Bartor Pharmacal Co., Inc. | 2009-09-02 | Traditional | PDF ↗ |
| K091419 | VICKS POWERSHOT DRY THROAT & MOUTH RELIEF | The Procter & Gamble Co. | 2009-08-28 | Traditional | PDF ↗ |
| K072306 | BIOXTRA MOISTURIZING GEL | Bio-X Healthcare S.A. | 2007-11-15 | Traditional | PDF ↗ |
| K071617 | ORAL NEUTRALIZER | Oral Biotech | 2007-10-19 | Traditional | PDF ↗ |
| K062653 | MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 | Parnell Pharmaceuticals, Inc. | 2006-10-27 | Traditional | PDF ↗ |
| K061331 | ORAL BALANCE LIQUID/ GEL | Laclede, Inc. | 2006-07-25 | Traditional | PDF ↗ |
| K051812 | TGO SPRAY | Laboratoires Carilene S.A.S. | 2005-10-21 | Traditional | PDF ↗ |
| K041563 | OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS | Glaxosmithkline Consumer Healthcare, L.P. | 2004-08-27 | Traditional | PDF ↗ |
| K030802 | CAPHOSOL | Inpharma A.S. | 2003-11-25 | Traditional | PDF ↗ |
| K024148 | SALINUM, ORCLAIR | Sinclair Pharmaceuticals, Ltd. | 2003-09-15 | Traditional | PDF ↗ |
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 | Gebauer Co. | 2001-08-06 | Traditional | PDF ↗ |
| K991938 | CAPHOSOL ARTIFICIAL SALIVA | Inpharma A.S. | 1999-08-10 | Traditional | PDF ↗ |
| K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA | Fresenius USA, Inc. | 1988-04-15 | Traditional | PDF ↗ |
| K851026 | MOI-STIR ORAL SWABSTICK(S) | Kingswood Laboratories, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K840807 | THROAT MOI-STIR | Kingswood Laboratories, Inc. | 1984-05-25 | Traditional | PDF ↗ |
| K822971 | SALIVA SUBSTITUTE | Roxane Laboratories, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K810157 | MOI-STIR | Kingswood Laboratories, Inc. | 1981-02-10 | Traditional | PDF ↗ |
Product code LFD · · Unknown. Data: openFDA.