Cleared Traditional

K051203 - BLUELEX

K051203 is an FDA 510(k) clearance for BLUELEX, manufactured by Monitex Industrial Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K051203 · Monitex Industrial Co., Ltd. · Dental device
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May 2005
Decision
14d
Days
Class 2
Risk

K051203 is an FDA 510(k) clearance for the BLUELEX. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Monitex Industrial Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on May 25, 2005 after a review of 14 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 - K051203

510(k) Number K051203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2005
Decision Date May 25, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
PAULA WILKERSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 195
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