Cleared Traditional

K160079 - rainbow Shine
(FDA 510(k) Clearance)

K160079 · Genoss Co., Ltd. · Dental

Nov 2016

Decision

301d

Days

Class 2

Risk

K160079 is an FDA 510(k) clearance for the rainbow Shine, 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 November 10, 2016, 301 days after receiving the submission on January 14, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K160079 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2016
Decision Date	November 10, 2016
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF