Cleared Traditional

K042199 - TRANSLUX POWER BLUE

K042199 is an FDA 510(k) clearance for TRANSLUX POWER BLUE, manufactured by Heraeus Kulzer,GmbH. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K042199 · Heraeus Kulzer,GmbH · Dental device
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Sep 2004
Decision
26d
Days
Class 2
Risk

K042199 is an FDA 510(k) clearance for the TRANSLUX POWER BLUE. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 26 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 - K042199

510(k) Number K042199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2004
Decision Date September 08, 2004
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
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 202
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K042199.
DEMETRON IDS CURING LIGHT
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SMARTLITE PS PEN-STYLE LED CURING LIGHT
K041372 · Dentsply International · Jun 2004
LED TURBO-PEN
K041303 · Apoza Enterprise Co., Ltd. · Jun 2004
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K040956 · First Medical Infection Control Associates, Inc. · Jun 2004
K042199 · TRANSLUX POWER BLUE
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