Cleared Traditional

K790833 - VISIO-BOND

K790833 is an FDA 510(k) clearance for VISIO-BOND, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway .

K790833 · Espe GmbH (Us) · Dental device
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Apr 1979
Decision
-
Days
Class 2
Risk

K790833 is an FDA 510(k) clearance for the VISIO-BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 - K790833

510(k) Number K790833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 30, 1979
Decision Date April 30, 1979
Days to Decision -
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 381
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K790833.
INSTANT BRIDGE
K802333 · Scientific Pharmaceuticals, Inc. · Nov 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · Den-Mat Corp. · May 1980
PRISMA-BOND
K801093 · Dentsply Intl. · May 1980
UVIOBOND
K771328 · Espe GmbH (Us) · Aug 1977
NIMETIC ETCHING GEL
K771325 · Espe GmbH (Us) · Aug 1977
NIMETIC BONDING MATERIAL
K771326 · Espe GmbH (Us) · Aug 1977