K203567 is an FDA 510(k) clearance for the Oral-B Dry Mouth Oral Rinse. This device is classified as a Saliva, Artificial.
Submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on April 5, 2021, 119 days after receiving the submission on December 7, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K203567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2020 |
| Decision Date | April 05, 2021 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |