Cleared Traditional

K063659 - EASY CURING PEN-STYLE LED CURING LIGHT

K063659 is an FDA 510(k) clearance for EASY CURING PEN-STYLE LED CURING LIGHT, manufactured by Dent Corp. Research & Development. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K063659 · Dent Corp. Research & Development · Dental device
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Apr 2007
Decision
143d
Days
Class 2
Risk

K063659 is an FDA 510(k) clearance for the EASY CURING PEN-STYLE LED CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dent Corp. Research & Development (White Plains, US). The FDA issued a Cleared decision on April 30, 2007 after a review of 143 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.

FDA 510(k) Submission Details - K063659

510(k) Number K063659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2006
Decision Date April 30, 2007
Days to Decision 143 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 128d · This submission: 143d
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 204
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K063659.
DOCTOR'S LIGHT LED DENTAL CURING LIGHT
K071908 · Good Doctors Co., Ltd. · Aug 2007
DEEP BLUE
K071722 · E.M.S Electro Medical Systems S.A · Aug 2007
DEMI
K071251 · Kerr Corporation · Jul 2007
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
K070373 · Apoza Enterprise Co., Ltd. · Mar 2007
PENCURE, MODEL VL-7
K063529 · J. Morita USA, Inc. · Jan 2007
BONART ART-L3 LED CURING LIGHT
K062289 · Bonart Co., Ltd. · Jan 2007
K063659 · EASY CURING PEN-STYLE LED CURING LIGHT
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