Cleared Special

K083647 - VALO

K083647 is the FDA 510(k) clearance for VALO by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Special 510(k) pathway after a 45-day FDA review.

K083647 · Ultradent Products, Inc. · Dental device
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Jan 2009
Decision
45d
Days
Class 2
Risk

K083647 is an FDA 510(k) clearance for the VALO, MODEL 5919. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 45 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K083647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date January 23, 2009
Days to Decision 45 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · This submission: 45d
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 64
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K083647.
BLUEPHASE STYLE
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BLUEPHASE 20I
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