Cleared Traditional

K941124 - STRUCTUR 2

K941124 is the FDA 510(k) clearance for STRUCTUR 2 by Voco GmbH. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K941124 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
35d
Days
Class 2
Risk

K941124 is an FDA 510(k) clearance for the STRUCTUR 2. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Voco GmbH (St. Louis, US). The FDA issued a Cleared decision on April 13, 1994 after a review of 35 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Voco GmbH devices

Submission Details

510(k) Number K941124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1994
Decision Date April 13, 1994
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K941124.
BELLEGLASHP
K955331 · Sybron Dental Specialties, Inc. · Jan 1996
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
GC PATTERN RESIN
K942670 · GC America, Inc. · Oct 1994
GC TEMPRON
K935960 · GC America, Inc. · Mar 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · 3M Company · Jan 1994
DENTALON PLUS MODIFICATION
K934283 · Heraeus Kulzer, Inc. · Dec 1993