Cleared Traditional

K143448 - Sonendo GentleWave System

K143448 is an FDA 510(k) clearance for Sonendo GentleWave System, manufactured by Sonendo, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K143448 · Sonendo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
150d
Days
Class 2
Risk

K143448 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 May 1, 2015 after a review of 150 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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. Standard predicate reliance. 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 Sonendo, Inc. devices

FDA 510(k) Submission Details - K143448

510(k) Number K143448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date May 01, 2015
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K143448.
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