Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
FDA 510(k) K173237 · Syendgen, Inc.
510(k) numberK173237
Submission
- Device name
- Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
- Applicant
- Syendgen, Inc.
Claremont, CA, US - Received
- October 5, 2017
- Decision date
- March 19, 2018
- 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 |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)LFD · Traditional | Laclede, Inc. | 04/19/2024SE |
| 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 |
Questions and answers
When was Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist cleared by the FDA?
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist (K173237) received a 510(k) decision of Substantially Equivalent on March 19, 2018, 165 days after the submission was received.
What is the product code of K173237?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.