Cleared Traditional

K133752 - SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CO...

K133752 is an FDA 510(k) clearance for SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CO..., 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 157-day FDA review.

K133752 · Sonendo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
157d
Days
Class 2
Risk

K133752 is an FDA 510(k) clearance for the SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDU.... 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 15, 2014 after a review of 157 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 - K133752

510(k) Number K133752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date May 15, 2014
Days to Decision 157 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
30d slower than avg
Panel avg: 127d · This submission: 157d
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 K133752.
AW-100
K171150 · Micron Corporation · Mar 2018
Cavitron Touch Ultrasonic Scaling System
K150535 · Dentsply International, Inc. · Jun 2015
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
K140990 · E.M.S Electro Medical Systems S.A · Feb 2015
PIEZON 250
K132445 · E.M.S Electro Medical Systems S.A · Dec 2013
PIEZON 150
K132443 · E.M.S Electro Medical Systems S.A · Nov 2013
ULTRASONIC SCALER
K113717 · Nakanishi, Inc. · Mar 2013