Cleared Special

K091894 - TEMPORARY C&B COMPOSITE

K091894 is an FDA 510(k) clearance for TEMPORARY C&B COMPOSITE, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBG cleared through the Special 510(k) pathway after a 29-day FDA review.

K091894 · Voco GmbH · Dental device
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Jul 2009
Decision
29d
Days
Class 2
Risk

K091894 is an FDA 510(k) clearance for the TEMPORARY C&B COMPOSITE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 23, 2009 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 - K091894

510(k) Number K091894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date July 23, 2009
Days to Decision 29 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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 186
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K091894.
DIRECT CROWN NATURAL 1
K101814 · Candulor USA, Inc. · Sep 2010
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
MIZZY EXPRESS
K093380 · Mycone Dental Supply Co., Inc. · Mar 2010
MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
K083195 · Lang Dental Mfg. Co., Inc. · Jun 2009
TEMPORARY COLD.V AND SELF-CURE DENTINE
K082700 · Major Prodotti Dentari S.P.A. · Dec 2008
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
K081705 · Lang Dental Mfg. Co., Inc. · Sep 2008
K091894 · TEMPORARY C&B COMPOSITE
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