Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
FDA 510(k) K240508 · Laclede, Inc.
510(k) numberK240508
Submission
- Device name
- Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
- Applicant
- Laclede, Inc.
Rancho Dominguez, CA, US - Received
- February 21, 2024
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFD – Saliva, Artificial
- Device class
- Unclassified
Other 510(k)s with product code LFD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253778 | Allday Moisturizing RinseLFD · Traditional | Elevate Oral Care | 02/27/2026SE |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth RinseLFD · Traditional | Rowpar Pharmaceuticals, Inc. | 05/19/2025SE |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional | Eusa Pharma (Uk) Limited | 03/11/2024SE |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayLFD · Traditional | Gurunanda, LLC | 08/22/2023SE |
| K202689 | Dentilube SprayLFD · Traditional | Oxy2plus, LLC | 09/03/2021SE |
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 09/02/2020SE |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional | Oralabs, Inc. | 11/21/2019SE |
| K190144 | MucoPEGLFD · Traditional | Sunbio, Inc. | 11/05/2019SE |
| K181194 | SmartMouth DryMouth Oral RinseLFD · Traditional | Triumph Pharmaceuticals, Inc. | 02/15/2019SE |
More from Triumph Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLFD · Traditional | 10/11/2018SE |
| K162235 | Luvena Vaginal Moisturizer & LubricantNUC · Traditional | 03/24/2017SE |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal LubricantNUC · Traditional | 12/29/2015SE |
| K061331 | Oral Balance Liquid/ GelLFD · Traditional | 07/25/2006SE |
Questions and answers
When was Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) cleared by the FDA?
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (K240508) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 58 days after the submission was received.
What is the product code of K240508?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.