Cleared Traditional

K071908 - DOCTOR'S LIGHT LED DENTAL CURING LIGHT

K071908 is an FDA 510(k) clearance for DOCTOR'S LIGHT LED DENTAL CURING LIGHT, manufactured by Good Doctors Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K071908 · Good Doctors Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
44d
Days
Class 2
Risk

K071908 is an FDA 510(k) clearance for the DOCTOR'S LIGHT LED DENTAL CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Good Doctors Co., Ltd. (Austin, US). The FDA issued a Cleared decision on August 23, 2007 after a review of 44 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Good Doctors Co., Ltd. devices

FDA 510(k) Submission Details - K071908

510(k) Number K071908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2007
Decision Date August 23, 2007
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
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 91
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K071908.
BLUEPHASE 20I
K091020 · Ivoclar Vivadent, Inc. · Jun 2009
VALO, MODEL 5919
K083647 · Ultradent Products, Inc. · Jan 2009
MINI LED AUTOFOCUS
K072181 · Satelec · Sep 2007
DEEP BLUE
K071722 · E.M.S Electro Medical Systems S.A · Aug 2007
DEMI
K071251 · Kerr Corporation · Jul 2007
PENCURE, MODEL VL-7
K063529 · J. Morita USA, Inc. · Jan 2007