Submission Details
| 510(k) Number | K073224 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 2007 |
| Decision Date | February 06, 2008 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K073224 is an FDA 510(k) clearance for the ORAL-B SUB-BRAND MANUAL TOOTHBRUSH, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Procter & Gamble (Mason, US). The FDA issued a Cleared decision on February 6, 2008, 83 days after receiving the submission on November 15, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.
| 510(k) Number | K073224 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 2007 |
| Decision Date | February 06, 2008 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFW — Toothbrush, Manual |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6855 |