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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Promident, LLC devices

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
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 98
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K172426.
Le'Pen
K181597 · Kmihh, Ltd. · Apr 2019
Dr's Light2
K173157 · Good Doctors Co., Ltd. · May 2018
Cybird LED Curing Light
K173876 · Dxm Co., Ltd. · Jan 2018
Demi Ultra
K163064 · Kerr Corporation · Jul 2017
Bluephase Style 20i
K163613 · Ivoclar Vivadent, AG · Apr 2017
VALO Grand
K160551 · Ultradent Products, Inc. · Jul 2016