Cleared Traditional

K172426 - Clear Blue Digi LED Curing Light

K172426 is an FDA 510(k) clearance for Clear Blue Digi LED Curing Light, manufactured by Promident, LLC. 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.

K172426 · Promident, LLC · Dental device
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Aug 2017
Decision
6d
Days
Class 2
Risk

K172426 is an FDA 510(k) clearance for the Clear Blue Digi LED Curing Light. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Promident, LLC (Valley Cottage, US). The FDA issued a Cleared decision on August 16, 2017 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.

FDA 510(k) Submission Details - K172426

510(k) Number K172426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2017
Decision Date August 16, 2017
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 128d · 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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

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
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K172426.
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
LED Curing Light
K161855 · Monitex Industrial Co., Ltd. · Nov 2017
Delight, Delight ortho, B&Lite S
K170529 · Dentall Co., Ltd. · Aug 2017
Demi Ultra
K163064 · Kerr Corporation · Jul 2017
Valiant Curing Light
K170101 · Inter-Med/Vista Dental Products · Jun 2017