Not Cleared Direct

DEN190039 - ToothWave™ (FDA 510(k) Clearance)

Class II Dental device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190039 · Home Skinovations , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
392d
Days
Class 2
Risk

DEN190039 is an FDA 510(k) submission (not cleared) for the ToothWave™. Classified as Powered Radiofrequency Toothbrush (product code QMJ), Class II - Special Controls.

Submitted by Home Skinovations , Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on September 17, 2020 after a review of 392 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6866 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 392 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Home Skinovations , Ltd. devices

Submission Details

510(k) Number DEN190039 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 22, 2019
Decision Date September 17, 2020
Days to Decision 392 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 127d · This submission: 392d
Pathway characteristics

Device Classification

Product Code QMJ Powered Radiofrequency Toothbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6866
Definition A Radiofrequency Toothbrush Is A Device That Consists Of A Handle Containing A Radiofrequency Generator To Deliver Radiofrequency Energy 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.