Cleared Traditional

K042153 - SOUTH BEACH SMILE LIGHT WHITENING SYSTEM

K042153 is an FDA 510(k) clearance for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM, manufactured by Dentovations, Inc.. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K042153 · Dentovations, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
91d
Days
Class 1
Risk

K042153 is an FDA 510(k) clearance for the SOUTH BEACH SMILE LIGHT WHITENING SYSTEM. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Dentovations, Inc. (Houston, US). The FDA issued a Cleared decision on November 8, 2004 after a review of 91 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K042153

510(k) Number K042153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date November 08, 2004
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
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.

Regulatory Peers - EEG Heat Source For Bleaching Teeth

All 10
Devices cleared under the same product code (EEG) and FDA review panel - the closest regulatory comparables to K042153.
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
K063704 · Beks Incorporated · Feb 2007
QUICKSMILE
K052040 · Cosmetic Dental Materials, Inc. · Oct 2005
SONX 35 ULTRASONIC BLEACHING SYSTEM
K041392 · CAO Group, Inc. · Nov 2004
UNION BROACH BLEACHING LIGHT
K895174 · Union Broach, Div. Moyco Industries, Inc. · Apr 1990
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
K884937 · Grass-Telefactor Product Group · Apr 1989
SCHEIN BLEACHING UNIT
K862385 · Henry Schein, Inc. · Oct 1986
K042153 · SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
Download PDF FDA Summary Dentovations, Inc.