Cleared Traditional

K833757 - VISIO-GEM

K833757 is the FDA 510(k) clearance for VISIO-GEM by Espe GmbH (Us). It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K833757 · Espe GmbH (Us) · Dental device
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Feb 1984
Decision
100d
Days
Class 2
Risk

K833757 is an FDA 510(k) clearance for the VISIO-GEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Anaheim, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 100 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

Submission Details

510(k) Number K833757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date February 03, 1984
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 591
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K833757.
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · Centrix, Inc. · Mar 1984
CURAY-MATCH PAINT-ON COMPOSITE RESTOR
K833810 · Scientific Pharmaceuticals, Inc. · Feb 1984
MATERIAL TOOTHSADE RESIN
K834247 · Scientific Pharmaceuticals, Inc. · Feb 1984
LUXENE VINYL-JECT 3600-80
K834046 · Howmedica Corp. · Feb 1984
CURAY-SUPPORT, CORE BUILD-UP MATERIAL
K832781 · Scientific Pharmaceuticals, Inc. · Oct 1983
DENTACOLOR LIGHT CURING CROWN & BRIDGE
K831215 · Kulzer, Inc. · Sep 1983