Cleared Traditional

POWER LED (K033697) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033697 · Dental Products of USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
94d
Days
Class 2
Risk

K033697 is an FDA 510(k) clearance for the POWER LED. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dental Products of USA, Inc. (Miami, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Dental Products of USA, Inc. devices

Submission Details

510(k) Number K033697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date February 27, 2004
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 36
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K033697.
Le'Pen
K181597 · Kmihh, Ltd. · Apr 2019
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994