Cleared Traditional

K790833 - VISIO-BOND

K790833 is the FDA 510(k) clearance for VISIO-BOND by Espe GmbH (Us). It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 291
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K790833.
HYDROXYLATE ENAMEL BOND SYSTEM
K810407 · Wallace A. Erickson & Co. · Mar 1981
INSTANT BRIDGE
K802333 · Scientific Pharmaceuticals, Inc. · Nov 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