Cleared Special

K113444 - N-HYBRIDE-COMPOSITE LC FLOW

K113444 is an FDA 510(k) clearance for N-HYBRIDE-COMPOSITE LC FLOW, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Special 510(k) pathway after a 30-day FDA review.

K113444 · Voco GmbH · Dental device
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Dec 2011
Decision
30d
Days
Class 2
Risk

K113444 is an FDA 510(k) clearance for the N-HYBRIDE-COMPOSITE LC FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on December 21, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Voco GmbH devices

FDA 510(k) Submission Details - K113444

510(k) Number K113444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date December 21, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 758
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K113444.
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K113563 · Voco GmbH · Dec 2011
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COMPONEER
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