Cleared Traditional

K041372 - SMARTLITE PS PEN-STYLE LED CURING LIGHT

K041372 is an FDA 510(k) clearance for SMARTLITE PS PEN-STYLE LED CURING LIGHT, manufactured by Dentsply International. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K041372 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
31d
Days
Class 2
Risk

K041372 is an FDA 510(k) clearance for the SMARTLITE PS PEN-STYLE LED CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on June 24, 2004 after a review of 31 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 Dentsply International devices

FDA 510(k) Submission Details - K041372

510(k) Number K041372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2004
Decision Date June 24, 2004
Days to Decision 31 days
Submission Type Traditional
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
97d faster than avg
Panel avg: 128d · This submission: 31d
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 177
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K041372.
SAVEDENT BLUE
K042196 · Denfotex Light Systems, Ltd. · Nov 2004
CYBIRD LED CURING LIGHT
K042703 · Dxm Co., Ltd. · Oct 2004
TRANSLUX POWER BLUE
K042199 · Heraeus Kulzer,GmbH · Sep 2004
LED TURBO-PEN
K041303 · Apoza Enterprise Co., Ltd. · Jun 2004
MINI L.E.D. OEM MODULE
K040808 · Satelec · Apr 2004
COLTOLUX LED CURING LIGHT
K040551 · Coltene/Whaledent, Inc. · Mar 2004