Cleared Traditional

K905604 - VISIO-GEM ART-SYSTEM

K905604 is an FDA 510(k) clearance for VISIO-GEM ART-SYSTEM, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K905604 · Espe GmbH (Us) · Dental device
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Mar 1991
Decision
108d
Days
Class 2
Risk

K905604 is an FDA 510(k) clearance for the VISIO-GEM ART-SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Espe GmbH (Us) devices

FDA 510(k) Submission Details - K905604

510(k) Number K905604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date March 29, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K905604.
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
PALFIQUE ESTELITE
K911524 · Tokuyama America, Inc. · May 1991
DURAFILL COLOR VS
K905131 · Kulzer, Inc. · Mar 1991
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991
MONOBOND S
K905220 · Ivoclar North America, Inc. · Dec 1990