Cleared Traditional

VONFLEX HEAVY, VINFLEX LIGHT

K103164 · Vericom Co., Ltd. · Dental
Nov 2010
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K103164 is an FDA 510(k) clearance for the VONFLEX HEAVY, VINFLEX LIGHT, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 10, 2010, 14 days after receiving the submission on October 27, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K103164 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2010
Decision Date November 10, 2010
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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