K201277 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 September 2, 2020, 112 days after receiving the submission on May 13, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K201277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2020 |
| Decision Date | September 02, 2020 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |