Cleared Traditional

K041392 - SONX 35 ULTRASONIC BLEACHING SYSTEM

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

K041392 is an FDA 510(k) clearance for SONX 35 ULTRASONIC BLEACHING SYSTEM, manufactured by CAO Group, Inc.. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 167-day FDA review.

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

FDA 510(k) Submission Details - K041392

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

EEG Device Classification - Class 1, General Controls

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.