Cleared Traditional

K123397 - MULTILINK AUTOMIX
(FDA 510(k) Clearance)

K123397 · Ivoclar Vivadent, AG · Dental
Jan 2013
Decision
87d
Days
Class 2
Risk

K123397 is an FDA 510(k) clearance for the MULTILINK AUTOMIX, 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 January 31, 2013, 87 days after receiving the submission on November 5, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K123397 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2012
Decision Date January 31, 2013
Days to Decision 87 days
Submission Type Traditional
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