TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
FDA 510(k) K171542 · Dr. Harold Katz, LLC (Dba Therabreath
510(k) numberK171542
Submission
- Device name
- TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
- Applicant
- Dr. Harold Katz, LLC (Dba Therabreath
Los Angeles, CA, US - Received
- May 26, 2017
- Decision date
- March 16, 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 TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges cleared by the FDA?
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (K171542) received a 510(k) decision of Substantially Equivalent on March 16, 2018, 294 days after the submission was received.
What is the product code of K171542?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.