Cleared Traditional

DENFIL

K042124 · Vericom Co., Ltd. · Dental
Aug 2004
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K042124 is an FDA 510(k) clearance for the DENFIL, 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 August 13, 2004, 7 days after receiving the submission on August 6, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K042124 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2004
Decision Date August 13, 2004
Days to Decision 7 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