Cleared Abbreviated

K072807 - I LIGHT

K072807 is an FDA 510(k) clearance for I LIGHT, manufactured by Dent'N CO. The device is a Class 2 Dental device with product code EBZ cleared through the Abbreviated 510(k) pathway after a 51-day FDA review.

K072807 · Dent'N CO · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
51d
Days
Class 2
Risk

K072807 is an FDA 510(k) clearance for the I LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dent'N CO (San Diego, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 51 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K072807

510(k) Number K072807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date November 21, 2007
Days to Decision 51 days
Submission Type Abbreviated
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
77d faster than avg
Panel avg: 128d · This submission: 51d
Pathway characteristics
Standards-based clearance path.

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 209
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K072807.
LED.L, LED.M, LED.G, LED.B
K080025 · Guilin Woodpecker Medical Instrument Co., Ltd. · Mar 2008
LED CURING LIGHT
K080035 · Monitex Industrial Co., Ltd. · Mar 2008
FLASHLITE REBEL*
K073518 · Discus Dental, Inc. · Dec 2007
MINI LED AUTOFOCUS
K072181 · Satelec · Sep 2007
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
K072807 · I LIGHT
Download PDF FDA Summary Dent'N CO