Cleared Special

K163064 - Demi Ultra (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163064 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
258d
Days
Class 2
Risk

K163064 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 July 18, 2017 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kerr Corporation devices

Submission Details

510(k) Number K163064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2016
Decision Date July 18, 2017
Days to Decision 258 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Modification to existing cleared device.

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 212
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