Cleared Traditional

Vericore Gradient Temporary Disc

K152443 · Whip Mix Corporation · Dental

May 2016

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K152443 is an FDA 510(k) clearance for the Vericore Gradient Temporary Disc, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Whip Mix Corporation (Louisville, US). The FDA issued a Cleared decision on May 11, 2016, 258 days after receiving the submission on August 27, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K152443 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2015
Decision Date	May 11, 2016
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF