Submission Details
| 510(k) Number | K141018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 21, 2014 |
| Decision Date | September 15, 2014 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
Sep 2014
Decision
147d
Days
Class 1
Risk
About This 510(k) Submission
K141018 is an FDA 510(k) clearance for the ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on September 15, 2014, 147 days after receiving the submission on April 21, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.
Device Classification
| Product Code | JEQ — Toothbrush, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6865 |
Manufacturer
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