Oral-B Dry Mouth Oral Rinse
FDA 510(k) K201277 · The Procter & Gamble Company
510(k) numberK201277
Submission
- Device name
- Oral-B Dry Mouth Oral Rinse
- Applicant
- The Procter & Gamble Company
Cincinnati, OH, US - Received
- May 13, 2020
- Decision date
- September 2, 2020
- 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 |
| 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 |
|---|---|---|
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 04/05/2021SE |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | 08/27/2020SE |
| K151413 | Always/Tampax bladder supportsHHW · Traditional | 12/18/2015SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | 09/15/2014SE |
| K133244 | Tampax M Plastic Tampons, UnscentedHEB · Special | 01/09/2014SE |
| K131543 | Tampax(R) L Plastic Tampons, UnscentedHEB · Special | 06/20/2013SE |
| K113699 | Tampax(R) V Plastic Applicator Tampons, UnscentedHEB · Special | 01/12/2012SE |
| K110669 | Tampax C Plastic Tampons, UnscentedHEB · Special | 06/02/2011SE |
| K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl…HEB · Traditional | 06/01/2010SE |
| K091964 | Crest Glide Clinical Gum Protection Dental FlossJES · Traditional | 09/24/2009SE |
Questions and answers
When was Oral-B Dry Mouth Oral Rinse cleared by the FDA?
Oral-B Dry Mouth Oral Rinse (K201277) received a 510(k) decision of Substantially Equivalent on September 2, 2020, 112 days after the submission was received.
What is the product code of K201277?
The FDA product code is LFD – Saliva, Artificial, a Unclassified device.