Cleared Traditional

K041303 - LED TURBO-PEN

K041303 is an FDA 510(k) clearance for LED TURBO-PEN, manufactured by Apoza Enterprise Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K041303 · Apoza Enterprise Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
32d
Days
Class 2
Risk

K041303 is an FDA 510(k) clearance for the LED TURBO-PEN. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Apoza Enterprise Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on June 18, 2004 after a review of 32 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.

FDA 510(k) Submission Details - K041303

510(k) Number K041303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date June 18, 2004
Days to Decision 32 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
96d faster than avg
Panel avg: 128d · This submission: 32d
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 204
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K041303.
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K040956 · First Medical Infection Control Associates, Inc. · Jun 2004
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K040808 · Satelec · Apr 2004
BLUEWAND LED DENTAL CURING WAND SYSTEM
K040614 · J.L. Blosser, Inc. · Apr 2004
K041303 · LED TURBO-PEN
Download PDF FDA Summary Apoza Enterprise Co.,…