Cleared Special

K070373 - APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W

K070373 is an FDA 510(k) clearance for APOZA LED CURING LIGHT, manufactured by Apoza Enterprise Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Special 510(k) pathway after a 22-day FDA review.

K070373 · Apoza Enterprise Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
22d
Days
Class 2
Risk

K070373 is an FDA 510(k) clearance for the APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Apoza Enterprise Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on March 2, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070373

510(k) Number K070373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date March 02, 2007
Days to Decision 22 days
Submission Type Special
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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 K070373.
DEEP BLUE
K071722 · E.M.S Electro Medical Systems S.A · Aug 2007
DEMI
K071251 · Kerr Corporation · Jul 2007
EASY CURING PEN-STYLE LED CURING LIGHT
K063659 · Dent Corp. Research & Development · Apr 2007
PENCURE, MODEL VL-7
K063529 · J. Morita USA, Inc. · Jan 2007
BONART ART-L3 LED CURING LIGHT
K062289 · Bonart Co., Ltd. · Jan 2007
DEMETRON A.2
K063116 · Sybron Dental Specialties · Dec 2006
K070373 · APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
Download PDF FDA Summary Apoza Enterprise Co.,…