Cleared Traditional

VISIO-FIL (K812169) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K812169.
AURAFILL* DENTAL RESTORATIVE
K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982
CAULK OPAQUER
K813357 · Dentsply Intl. · Jan 1982
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · 3M Company · Mar 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · Dentsply Intl. · Jan 1981