Cleared Traditional

DENFIL FLOW

K060637 · Vericom Co., Ltd. · Dental
Mar 2006
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K060637 is an FDA 510(k) clearance for the DENFIL FLOW, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 16, 2006, 6 days after receiving the submission on March 10, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K060637 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2006
Decision Date March 16, 2006
Days to Decision 6 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