Cleared Traditional

SONX 35 ULTRASONIC BLEACHING SYSTEM (K041392) - FDA 510(k) Clearance

Also marketed or referenced as:
SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US

Class I Dental device.

K041392 · CAO Group, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
167d
Days
Class 1
Risk

K041392 is an FDA 510(k) clearance for the SONX 35 ULTRASONIC BLEACHING SYSTEM. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by CAO Group, Inc. (Sandy, US). The FDA issued a Cleared decision on November 8, 2004 after a review of 167 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6475 - 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 CAO Group, Inc. devices

Submission Details

510(k) Number K041392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date November 08, 2004
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EEG Heat Source For Bleaching Teeth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.