Cleared Traditional

Vonflex S Putty

K152518 · Vericom Co., Ltd. · Dental
Nov 2015
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K152518 is an FDA 510(k) clearance for the Vonflex S Putty, 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 30, 2015, 88 days after receiving the submission on September 3, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K152518 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2015
Decision Date November 30, 2015
Days to Decision 88 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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