Cleared Abbreviated

MERIDIAN

K131753 · Ab Ardent · Dental
Nov 2013
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K131753 is an FDA 510(k) clearance for the MERIDIAN, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ab Ardent (Amherst, US). The FDA issued a Cleared decision on November 14, 2013, 153 days after receiving the submission on June 14, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K131753 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2013
Decision Date November 14, 2013
Days to Decision 153 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