K200881 is an FDA 510(k) clearance for the Oral-B iO Test Drive Power Brush Trial Program Kit. This device is classified as a Toothbrush, Powered (Class I - General Controls, product code JEQ).
Submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on August 27, 2020, 147 days after receiving the submission on April 2, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6865.
| 510(k) Number | K200881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2020 |
| Decision Date | August 27, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEQ - Toothbrush, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6865 |