Cleared Special

Sonendo GentleWave System (K190359) - FDA 510(k) Clearance

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

K190359 · Sonendo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
29d
Days
Class 2
Risk

K190359 is an FDA 510(k) clearance for the Sonendo GentleWave System. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sonendo, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 16, 2019 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sonendo, Inc. devices

Submission Details

510(k) Number K190359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date March 16, 2019
Days to Decision 29 days
Submission Type Special
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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 Peers - ELC Scaler, Ultrasonic

All 35
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K190359.
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
K190124 · E.M.S Electro Medical Systems S.A · Oct 2019
Piezon Built-in Kit, Piezon Built-in Kit LED
K191079 · E.M.S Electro Medical Systems S.A · Aug 2019
tün® ultrasonic tips product family
K182145 · Engineered Endodontics · Jun 2019
AW-100
K171150 · Micron Corporation · Mar 2018
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · Dentsply Intl. · Sep 2005
CARRIER TIPS
K031461 · Dentsply Intl. · Aug 2003