# DEN190039: ToothWave™

- Pathway: De Novo (Direct)
- Applicant: Home Skinovations, Ltd.
- Decided: Sep 17, 2020 after 392 days
- Product code: QMJ (Powered Radiofrequency Toothbrush)
- Device class: 2
- Regulation: 21 CFR 872.6866
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K214078: Silk’n Toothwave (2023), 0 descendants of its own

## Indications for use
ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.

Source page: https://510kreport.com/device/DEN190039
Methodology: https://510kreport.com/methodology