K926246 is an FDA 510(k) clearance for the OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142. This device is classified as a Toothbrush, Powered (Class I - General Controls, product code JEQ).
Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on April 14, 1993, 121 days after receiving the submission on December 14, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6865.
| 510(k) Number | K926246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1992 |
| Decision Date | April 14, 1993 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JEQ — Toothbrush, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6865 |