Cleared Special

K113563 - N-HYBRIDE-COMPOSITE LC

K113563 is an FDA 510(k) clearance for N-HYBRIDE-COMPOSITE LC, 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.

K113563 · Voco GmbH · Dental device
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Dec 2011
Decision
30d
Days
Class 2
Risk

K113563 is an FDA 510(k) clearance for the N-HYBRIDE-COMPOSITE LC. 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.

FDA 510(k) Submission Details - K113563

510(k) Number K113563 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
98d faster than avg
Panel avg: 128d · 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 912
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K113563.
SPEE-DEE PATCH
K113617 · Pulpdent Corporation · Mar 2012
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
K112044 · Anaxdent GmbH · Jan 2012
N-HYBRIDE-COMPOSITE LC FLOW
K113444 · Voco GmbH · Dec 2011
VENUS PEARL PLT REFILL A1
K112501 · Heraeus Kulzer, LLC · Dec 2011
COMPONEER
K112168 · Coltene/Whaledent AG · Nov 2011
CLEARFIL DC CORE PLUS
K111982 · Kuraray America, Inc. · Nov 2011
K113563 · N-HYBRIDE-COMPOSITE LC
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