FDA product code LFD: Saliva, Artificial
LFD is the FDA product code for saliva, artificial. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 50 510(k) submissions under LFD, 5 in the last five years, from 40 different applicants. The average 510(k) review took 182 days (median 122); 87 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 6 recalls for LFD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Saliva, Artificial |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LFD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 207 |
| 2018 | 5 | 193 |
| 2019 | 3 | 355 |
| 2020 | 1 | 112 |
| 2021 | 2 | 236 |
| 2023 | 1 | 117 |
| 2024 | 2 | 70 |
| 2025 | 1 | 97 |
| 2026 | 1 | 93 |
Compare with all 510(k) review times · Search every LFD clearance
Top LFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laclede, Inc. | 3 | 2024-04-19 |
| Glaxosmithkline Consumer Healthcare (Gskch) | 3 | 2013-01-04 |
| Kingswood Laboratories, Inc. | 3 | 1985-05-21 |
| Elevate Oral Care | 2 | 2026-02-27 |
| Eusa Pharma (Uk) Limited | 2 | 2024-03-11 |
35 more applicants have LFD clearances. See the full list in Caduvo.
Most recent LFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253778 | Elevate Oral Care | Allday Moisturizing Rinse | 2026-02-27 | 93 |
| K250390 | Rowpar Pharmaceuticals, Inc. | CloSYS® Dry Mouth Sensitive Mouth Rinse | 2025-05-19 | 97 |
| K240508 | Laclede, Inc. | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | 2024-04-19 | 58 |
| K234015 | Eusa Pharma (Uk) Limited | Caphosol® Artifical Saliva (32 doses sachet box) | 2024-03-11 | 83 |
| K231205 | Gurunanda, LLC | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | 2023-08-22 | 117 |
Recalls for LFD devices
6 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-11.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LFD?
LFD is the FDA product code for saliva, artificial. It is a Unclassified device, reviewed by the Dental panel.
What device class is LFD?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFD?
Across 50 cleared submissions the average was 182 days from receipt to decision (median 122).
Which companies have the most LFD clearances?
Laclede, Inc. (3); Glaxosmithkline Consumer Healthcare (Gskch) (3); Kingswood Laboratories, Inc. (3); Elevate Oral Care (2); Eusa Pharma (Uk) Limited (2).
Have LFD devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2025-06-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LFD
- Run a recall and safety report across every LFD manufacturer
- Watch product code LFD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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