Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LFD — Predicate Candidate Screening
50 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
353 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 | 93 | 0 |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. | 2025-05-19 | 97 | 0 |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing G | Laclede, Inc. | 2024-04-19 | 58 | 0 |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | 2024-03-11 | 83 | 1 |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral | Gurunanda, LLC | 2023-08-22 | 117 | 0 |
| K202689 | Dentilube Spray | Oxy2plus, LLC | 2021-09-03 | 353 | 0 |
| K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021-04-05 | 119 | 0 |
| K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020-09-02 | 112 | 0 |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Oralabs, Inc. | 2019-11-21 | 498 | 0 |
| K190144 | MucoPEG | Sunbio, Inc. | 2019-11-05 | 280 | 0 |
| K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. | 2019-02-15 | 287 | 0 |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018-10-11 | 210 | 0 |
| K173808 | Voutia™ | Jeffrey Ward Cash, Dds | 2018-07-27 | 224 | 0 |
| K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral | Sunstar Americas, Inc. | 2018-07-13 | 74 | 0 |
| K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moi | Syendgen, Inc. | 2018-03-19 | 165 | 0 |
| K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Loze | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 | 294 | 0 |
| K163029 | Hydris™ Oral Rinse | Biopharm Consult, LLC | 2017-06-19 | 231 | 0 |
| K163476 | Lubricity | You First Services, Incorporated | 2017-05-10 | 149 | 0 |
| K162167 | Caphosol Artifical Saliva Tablets | Eusa Pharma (Uk) Limited | 2017-03-31 | 240 | 0 |
| K152201 | MedActive Oral Gel and Spray | Medactive Oral Pharmaceuticals, LLC | 2015-12-30 | 146 | 0 |
| K152406 | SalivaMAX | Forward Science, LLC | 2015-12-23 | 120 | 0 |
| K142657 | XEROSTOM SALIVA SUBSTITUTE GEL | Bio Cosmetics, S.L. | 2015-09-14 | 361 | 0 |
| K150074 | Elevate Moisturizing Spray | Elevate Oral Care | 2015-06-19 | 156 | 0 |
| K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | 2015-05-26 | 258 | 0 |
| K122663 | ORAMOIST | Quantum, Inc. | 2013-05-30 | 272 | 0 |
| K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOT | Glaxosmithkline Consumer Healthcare (Gskch) | 2013-01-04 | 30 | 1 |
| K120552 | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA | Biocosmetics Laboratories | 2012-06-06 | 104 | 0 |
| K111250 | DRY MOUTH MOUTHWASH | Dr. Fresh, Inc. | 2012-04-27 | 359 | 0 |
| K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIE | Glaxosmithkline Consumer Healthcare (Gskch) | 2011-07-20 | 209 | 0 |
| K110116 | XEROS DRY MOUTH PUMP | Lorin Technologies Corporation | 2011-04-08 | 84 | 0 |
| K101346 | GC ORAL MOISTURIZING GEL | GC America, Inc. | 2011-01-27 | 259 | 0 |
| K101477 | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH | Glaxosmithkline Consumer Healthcare (Gskch) | 2010-09-28 | 123 | 0 |
| K093642 | NEUTRASAL | Invado Pharmaceuticals | 2009-12-11 | 17 | 0 |
| K091718 | NEUTRASAL | Bartor Pharmacal Co., Inc. | 2009-09-02 | 83 | 0 |
| K091419 | VICKS POWERSHOT DRY THROAT & MOUTH RELIEF | The Procter & Gamble Co. | 2009-08-28 | 107 | 0 |
| K072306 | BIOXTRA MOISTURIZING GEL | Bio-X Healthcare S.A. | 2007-11-15 | 90 | 0 |
| K071617 | ORAL NEUTRALIZER | Oral Biotech | 2007-10-19 | 128 | 0 |
| K062653 | MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 | Parnell Pharmaceuticals, Inc. | 2006-10-27 | 50 | 0 |
| K061331 | ORAL BALANCE LIQUID/ GEL | Laclede, Inc. | 2006-07-25 | 74 | 0 |
| K051812 | TGO SPRAY | Laboratoires Carilene S.A.S. | 2005-10-21 | 108 | 0 |
| K041563 | OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DIS | Glaxosmithkline Consumer Healthcare, L.P. | 2004-08-27 | 78 | 0 |
| K030802 | CAPHOSOL | Inpharma A.S. | 2003-11-25 | 257 | 0 |
| K024148 | SALINUM, ORCLAIR | Sinclair Pharmaceuticals, Ltd. | 2003-09-15 | 273 | 0 |
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART | Gebauer Co. | 2001-08-06 | 1181 | 2 |
| K991938 | CAPHOSOL ARTIFICIAL SALIVA | Inpharma A.S. | 1999-08-10 | 62 | 0 |
| K874106 | GLANDOSANE (SALIVART) SYNTHETIC SALIVA | Fresenius USA, Inc. | 1988-04-15 | 189 | 0 |
| K851026 | MOI-STIR ORAL SWABSTICK(S) | Kingswood Laboratories, Inc. | 1985-05-21 | 70 | 1 |
| K840807 | THROAT MOI-STIR | Kingswood Laboratories, Inc. | 1984-05-25 | 91 | 0 |
| K822971 | SALIVA SUBSTITUTE | Roxane Laboratories, Inc. | 1982-11-16 | 39 | 0 |
| K810157 | MOI-STIR | Kingswood Laboratories, Inc. | 1981-02-10 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda