Cleared Traditional

SPACER

K072069 · Vericom Co., Ltd. · Dental
Sep 2007
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K072069 is an FDA 510(k) clearance for the SPACER, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Vericom Co., Ltd. (Mission Viejo, US). The FDA issued a Cleared decision on September 28, 2007, 60 days after receiving the submission on July 30, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K072069 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2007
Decision Date September 28, 2007
Days to Decision 60 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