Cleared Traditional

rainbow Paste Stain SE

K233885 · Genoss Co., Ltd. · Dental
Jun 2024
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K233885 is an FDA 510(k) clearance for the rainbow Paste Stain SE, 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 June 21, 2024, 196 days after receiving the submission on December 8, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K233885 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2023
Decision Date June 21, 2024
Days to Decision 196 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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