Product code LFD
- Device name
- Saliva, Artificial
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P790016 | SALIVART | Westport Pharmaceuticals, Inc. | 1979-09-19 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. | 2025-05-19 |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024-04-19 |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | 2024-03-11 |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | Gurunanda, LLC | 2023-08-22 |
| K202689 | Dentilube Spray | Oxy2plus, LLC | 2021-09-03 |
| K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021-04-05 |
| K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020-09-02 |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Oralabs, Inc. | 2019-11-21 |
| K190144 | MucoPEG | Sunbio, Inc. | 2019-11-05 |
| K181194 | SmartMouth DryMouth Oral Rinse | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018-10-11 |
| K173808 | Voutia™ | Jeffrey Ward Cash, Dds | 2018-07-27 |
| K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray | Sunstar Americas, Inc. | 2018-07-13 |
| 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 |
| K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 |
| K163029 | Hydris™ Oral Rinse | Biopharm Consult, LLC | 2017-06-19 |
| K163476 | Lubricity | You First Services, Incorporated | 2017-05-10 |
| K162167 | Caphosol Artifical Saliva Tablets | Eusa Pharma (Uk) Limited | 2017-03-31 |
| K152201 | MedActive Oral Gel and Spray | Medactive Oral Pharmaceuticals, LLC | 2015-12-30 |
| K152406 | SalivaMAX | Forward Science, LLC | 2015-12-23 |
| K142657 | XEROSTOM SALIVA SUBSTITUTE GEL | Bio Cosmetics, S.L. | 2015-09-14 |
| K150074 | Elevate Moisturizing Spray | Elevate Oral Care | 2015-06-19 |
| 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 |
| K122663 | ORAMOIST | Quantum, Inc. | 2013-05-30 |
| K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | Glaxosmithkline Consumer Healthcare (Gskch) | 2013-01-04 |
| K120552 | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA | Biocosmetics Laboratories | 2012-06-06 |
| K111250 | DRY MOUTH MOUTHWASH | Dr. Fresh, Inc. | 2012-04-27 |
| K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | Glaxosmithkline Consumer Healthcare (Gskch) | 2011-07-20 |
| K110116 | XEROS DRY MOUTH PUMP | Lorin Technologies Corporation | 2011-04-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00350930098029 | Parnell Pharmaceuticals, Inc. | Parnell Pharmaceuticals, Inc. | 2026-05-21 |
| 00350930098081 | Parnell Pharmaceuticals, Inc. | Parnell Pharmaceuticals, Inc. | 2026-05-21 |
| 00858290006987 | Allday Oral Moisturizing Rinse, 10oz Bottle | ELEVATE ORAL CARE, LLC | 2026-05-01 |
| 00810051089479 | GuruNanda | Gurunanda, LLC | 2026-01-28 |
| 00810051089004 | GuruNanda | Gurunanda, LLC | 2026-01-28 |
| 00647692000132 | CloSYS Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. | 2025-12-16 |
| 00899655002220 | Salivea | LACLEDE, INC. | 2025-06-16 |
| 00697366003570 | SmartMouth | Triumph Pharmaceuticals Inc. | 2025-06-10 |
| 00697366003556 | SmartMouth | Triumph Pharmaceuticals Inc. | 2025-06-10 |
| 00850058655109 | Periovance Dry Mouth Gel | ORABIO, INC. | 2025-04-09 |
| 00850058655055 | Periovance Dry Mouth Gel | ORABIO, INC. | 2025-04-09 |
| 00850058655086 | Periovance Dry Mouth Gel | ORABIO, INC. | 2025-04-09 |
| 05060146293129 | Caphosol® Artifical Saliva | EUSA PHARMA (UK) LIMITED | 2024-06-26 |
| 08426181972769 | Xerostom® Saliva Substitute Gel | BIO COSMETICS SL | 2024-04-01 |
| 05060146291576 | Caphosol | EUSA PHARMA (UK) LIMITED | 2024-03-27 |
| 00304369600421 | Moi-stir 4 oz w/ sprayer | Century Pharmaceuticals Inc | 2024-02-14 |
| D132DMS0030 | Meijer | Oralabs, LLC | 2024-01-29 |
| D132DMS0020 | CVS Dry Mouth Spray | Oralabs, LLC | 2024-01-29 |
| 00899655002251 | Salivea | LACLEDE, INC. | 2023-09-12 |
| 00899655002275 | Salivea | LACLEDE, INC. | 2023-09-12 |
| 00697029774694 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-15 |
| 00697029724729 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-15 |
| 00697029340103 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-15 |
| 00697029241127 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-15 |
| 00697029118832 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-15 |
| 00697029471005 | THERABREATH LOZENGE | CHURCH & DWIGHT CO., INC. | 2023-02-14 |
| 00050428396841 | CVS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2022-09-23 |
| 00050428293416 | CVS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2022-08-08 |
| 30348878600023 | 3M™ ESPE™ | 3M COMPANY | 2018-10-31 |
| 30348878600016 | 3M™ ESPE™ | 3M COMPANY | 2018-10-31 |