Cleared Abbreviated

K142389 - Variolink Esthetic

K142389 is an FDA 510(k) clearance for Variolink Esthetic, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K142389 · Ivoclar Vivadent, AG · Dental device
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Nov 2014
Decision
90d
Days
Class 2
Risk

K142389 is an FDA 510(k) clearance for the Variolink Esthetic. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on November 25, 2014 after a review of 90 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ivoclar Vivadent, AG devices

FDA 510(k) Submission Details - K142389

510(k) Number K142389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date November 25, 2014
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Ivoclar Vivadent, Inc.
DONNA MARIE HARTNETT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

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