Cleared Abbreviated

TETRIC EVOFLOW BULK FILL

K150393 · Ivoclar Vivadent, AG · Dental
Jun 2015
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K150393 is an FDA 510(k) clearance for the TETRIC EVOFLOW BULK FILL, 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 June 9, 2015, 111 days after receiving the submission on February 18, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K150393 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2015
Decision Date June 09, 2015
Days to Decision 111 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