21 CFR 872.6865 — Toothbrush, Powered
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6865
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JEQ | Toothbrush, Powered | 1 | 54 | |
| MMD | Toothbrush, Ionic, Battery-Powered | 1 | 2 | |
| QIA | Powered Tongue Scraper | 1 | 1 | SaMD |
