The following data is part of a premarket notification filed by The Proctor & Gamble Company with the FDA for Oral-b Dry Mouth Oral Rinse.
| Device ID | K201277 |
| 510k Number | K201277 |
| Device Name: | Oral-B Dry Mouth Oral Rinse |
| Classification | Saliva, Artificial |
| Applicant | The Proctor & Gamble Company 1 Proctor & Gamble Plaza Cincinnati, OH 45202 |
| Contact | Michael A Kaminski |
| Correspondent | Michael A Kaminski The Proctor & Gamble Company 8700 Mason Montgomery Road Mason, OH 45040 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-13 |
| Decision Date | 2020-09-02 |