Cleared Traditional

K833757 - VISIO-GEM

K833757 is an FDA 510(k) clearance for VISIO-GEM, 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 100-day FDA review.

K833757 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K833757

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.

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 K833757.
REMBRANDT SHADE MODIFICATION KIT
K841111 · Den-Mat Corp. · 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