Cleared Traditional

Vonflex S

K152615 · Vericom Co., Ltd. · Dental
Nov 2016
Decision
416d
Days
Class 2
Risk

About This 510(k) Submission

K152615 is an FDA 510(k) clearance for the Vonflex S, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on November 3, 2016, 416 days after receiving the submission on September 14, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K152615 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2015
Decision Date November 03, 2016
Days to Decision 416 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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