Cleared Traditional

K051571 - SKYLIGHT LED CURING LIGHT

K051571 is an FDA 510(k) clearance for SKYLIGHT LED CURING LIGHT, manufactured by Dmetec.Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K051571 · Dmetec.Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
35d
Days
Class 2
Risk

K051571 is an FDA 510(k) clearance for the SKYLIGHT LED CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dmetec.Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 35 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 Dmetec.Co., Ltd. devices

FDA 510(k) Submission Details - K051571

510(k) Number K051571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date July 19, 2005
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
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 98
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K051571.
BISCO LED
K052122 · Bisco, Inc. · Mar 2006
BLUEPHASE 16I
K051782 · Ivoclar Vivadent, Inc. · Sep 2005
JETLITE 5000
K051780 · J. Morita USA, Inc. · Jul 2005
L.E. DEMETRON II
K051545 · Kerr Corporation (Danbury) · Jul 2005
G-LIGHT
K050059 · GC America, Inc. · Feb 2005
SMARTLITE PS PEN-STYLE LED CURING LIGHT
K041372 · Dentsply International · Jun 2004