Cleared Traditional

K063704 - BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101

K063704 is an FDA 510(k) clearance for BRITEWHITE TEETH WHITENING SYSTEM, manufactured by Beks Incorporated. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K063704 · Beks Incorporated · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
69d
Days
Class 1
Risk

K063704 is an FDA 510(k) clearance for the BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Beks Incorporated (Carol Stream, US). The FDA issued a Cleared decision on February 20, 2007 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beks Incorporated devices

FDA 510(k) Submission Details - K063704

510(k) Number K063704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date February 20, 2007
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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.