Cleared Traditional

ECO-S

K103121 · Vericom Co., Ltd. · Dental
Oct 2010
Decision
4d
Days
Class 2
Risk

About This 510(k) Submission

K103121 is an FDA 510(k) clearance for the ECO-S, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 26, 2010, 4 days after receiving the submission on October 22, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K103121 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2010
Decision Date October 26, 2010
Days to Decision 4 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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