MMD · Toothbrush, Ionic, Battery-Powered
Dental · 21 CFR 872.6865 · Class 1
Overview
| Product Code | MMD |
|---|---|
| Device Name | Toothbrush, Ionic, Battery-Powered |
| Regulation | 21 CFR 872.6865 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971639 | PLUSTRON ION TOOTHBRUSH SYSTEM | Sas Group, Inc. | Jun 24, 1997 | SESE |
| K915576 | HUBUKA HYG TOOTHBRUSH | Hukuba Dental Corp. | Mar 4, 1994 | SESE |
Top Applicants
- Hukuba Dental Corp. — 1 clearance
- Sas Group, Inc. — 1 clearance
