Cleared Traditional

K812169 - VISIO-FIL

K812169 is the FDA 510(k) clearance for VISIO-FIL by Espe GmbH (Us). It is a Class 2 Chemistry device (product code EBF) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K812169 · Espe GmbH (Us) · Chemistry device
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Sep 1981
Decision
40d
Days
Class 2
Risk

K812169 is an FDA 510(k) clearance for the VISIO-FIL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 872.3690 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Espe GmbH (Us) devices

Submission Details

510(k) Number K812169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1981
Decision Date September 08, 1981
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 Chemistry 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 K812169.
CAULK OPAQUER
K813357 · Dentsply Intl. · Jan 1982
ESTILUX POSTERIOR
K812889 · Kulzer, Inc. · Nov 1981
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM
K811427 · Harry J. Bosworth Co. · Aug 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · Kulzer, Inc. · Jul 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981