Cleared Traditional

K214078 - Silk’n Toothwave (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214078 · Home Skinovations , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
382d
Days
Class 2
Risk

K214078 is an FDA 510(k) clearance for the Silk’n Toothwave. Classified as Powered Radiofrequency Toothbrush (product code QMJ), Class II - Special Controls.

Submitted by Home Skinovations , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on January 13, 2023 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Home Skinovations , Ltd. devices

Submission Details

510(k) Number K214078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date January 13, 2023
Days to Decision 382 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 127d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

A. Stein Regulatory Affairs Consulting , Ltd.
Amit Goren

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.