Cleared Traditional

rainbow LS Block

K160144 · Genoss Co., Ltd. · Dental
Jul 2016
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K160144 is an FDA 510(k) clearance for the rainbow LS Block, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 21, 2016, 182 days after receiving the submission on January 21, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K160144 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2016
Decision Date July 21, 2016
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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