Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
fda-device · Food and Drug Administration · Rule · Published 2024-09-05 · Effective 2024-09-05 · 89 FR 72320
Document
Document number
2024-19868
Federal Register citation
89 FR 72320
CFR reference
21 CFR 872
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-05
Effective date
2024-09-05
HHS docket
Docket No. FDA-2024-N-3973
Abstract
The Food and Drug Administration (FDA or we) is classifying the radiofrequency toothbrush into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiofrequency toothbrush's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.