Cleared Traditional

K040808 - MINI L.E.D. OEM MODULE

K040808 is an FDA 510(k) clearance for MINI L.E.D. OEM MODULE, manufactured by Satelec. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K040808 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
30d
Days
Class 2
Risk

K040808 is an FDA 510(k) clearance for the MINI L.E.D. OEM MODULE. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 30 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 Satelec devices

FDA 510(k) Submission Details - K040808

510(k) Number K040808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date April 28, 2004
Days to Decision 30 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: 127d · This submission: 30d
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 88
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K040808.
L.E. DEMETRON II
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SMARTLITE PS PEN-STYLE LED CURING LIGHT
K041372 · Dentsply International · Jun 2004
BLUEPHASE
K033520 · Ivoclar Vivadent, Inc. · Dec 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · Satelec · Oct 2003
SLED CURING LIGHT SYSTEM
K031615 · Dentsply International · Jul 2003