Cleared Traditional

K030641 - CONTEC LIGHT

K030641 is an FDA 510(k) clearance for CONTEC LIGHT, manufactured by Dentaurum. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K030641 · Dentaurum · Dental device
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Jun 2003
Decision
102d
Days
Class 2
Risk

K030641 is an FDA 510(k) clearance for the CONTEC LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentaurum (Newtown, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 102 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 Dentaurum devices

FDA 510(k) Submission Details - K030641

510(k) Number K030641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date June 10, 2003
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

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 121
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K030641.
BLUEPHASE
K033520 · Ivoclar Vivadent, Inc. · Dec 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · Satelec · Oct 2003
SLED CURING LIGHT SYSTEM
K031615 · Dentsply International · Jul 2003
RADII
K030568 · Southern Dental Industries, Inc. · Apr 2003
PALMLIGHT
K020057 · CAO Group, Inc. · Aug 2002
L.E.DEMETRON
K021797 · Sybron Dental Specialties, Inc. · Jun 2002