Cleared Traditional

DENFIL ETCHANT-37

K080265 · Vericom Co., Ltd. · Dental
Feb 2008
Decision
5d
Days
Class 2
Risk

About This 510(k) Submission

K080265 is an FDA 510(k) clearance for the DENFIL ETCHANT-37, 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 February 6, 2008, 5 days after receiving the submission on February 1, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K080265 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2008
Decision Date February 06, 2008
Days to Decision 5 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