Cleared Traditional

K073518 - FLASHLITE REBEL*

K073518 is an FDA 510(k) clearance for FLASHLITE REBEL*, manufactured by Discus Dental, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K073518 · Discus Dental, Inc. · Dental device
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Dec 2007
Decision
6d
Days
Class 2
Risk

K073518 is an FDA 510(k) clearance for the FLASHLITE REBEL*. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Discus Dental, Inc. (Culver City, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 6 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 Discus Dental, Inc. devices

FDA 510(k) Submission Details - K073518

510(k) Number K073518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date December 20, 2007
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
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 Peers - EBZ Activator, Ultraviolet, For Polymerization

All 113
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