Cleared Abbreviated

Variolink Esthetic

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

About This 510(k) Submission

K142389 is an FDA 510(k) clearance for the Variolink Esthetic, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on November 25, 2014, 90 days after receiving the submission on August 27, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K142389 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690