Cleared Traditional

K123468 - DEMI ULTRA

K123468 is the FDA 510(k) clearance for DEMI ULTRA by Kerr Corporation. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K123468 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
131d
Days
Class 2
Risk

K123468 is an FDA 510(k) clearance for the DEMI ULTRA. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on March 20, 2013 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kerr Corporation devices

Submission Details

510(k) Number K123468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2012
Decision Date March 20, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K123468.
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BLUEPHASE STYLE
K110756 · Ivoclar Vivadent, Inc. · Aug 2011
VALO CORDLESS
K110582 · Ultradent Products, Inc. · Apr 2011
BLUEPHASE 20I
K091020 · Ivoclar Vivadent, Inc. · Jun 2009