Cleared Traditional

K143104 - Visalys Core

K143104 is an FDA 510(k) clearance for Visalys Core, manufactured by Kettenbach GmbH & Co. KG. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K143104 · Kettenbach GmbH & Co. KG · Dental device
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Mar 2015
Decision
147d
Days
Class 2
Risk

K143104 is an FDA 510(k) clearance for the Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on March 25, 2015 after a review of 147 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 Kettenbach GmbH & Co. KG devices

FDA 510(k) Submission Details - K143104

510(k) Number K143104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2014
Decision Date March 25, 2015
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 127d · This submission: 147d
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 649
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K143104.
Mosaic Universal Composite
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TETRIC EVOFLOW BULK FILL
K150393 · Ivoclar Vivadent, AG · Jun 2015
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
ABSOLUTE DENTIN 2
K132115 · Parkell, Inc. · Jun 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · Prismatik Dentalcraft, Inc. · Jun 2014