Cleared Special

K040769 - STRUCTUR 2 SC

K040769 is an FDA 510(k) clearance for STRUCTUR 2 SC, 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 13-day FDA review.

K040769 · Voco GmbH · Dental device
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Apr 2004
Decision
13d
Days
Class 2
Risk

K040769 is an FDA 510(k) clearance for the STRUCTUR 2 SC. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Voco GmbH (Bend, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 13 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.

View all Voco GmbH devices

FDA 510(k) Submission Details - K040769

510(k) Number K040769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2004
Decision Date April 07, 2004
Days to Decision 13 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
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 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K040769.
PROVISO
K041886 · Scientific Pharmaceuticals, Inc. · Aug 2004
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004
COOL TEMP NATURAL
K041098 · Coltene AG · May 2004
LUXAFORM PLUS
K033227 · Dmg USA, Inc. · Jan 2004
LEXATITE QUICK ACRYLIC
K033432 · Imtec Corp. · Jan 2004
PROTEMP 3 GARANT
K033022 · 3M Espe AG Dental Products · Nov 2003