Cleared Traditional

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

K232174 · Genoss Co., Ltd. · Dental
Feb 2024
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K232174 is an FDA 510(k) clearance for the rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Genoss Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 23, 2024, 217 days after receiving the submission on July 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K232174 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2023
Decision Date February 23, 2024
Days to Decision 217 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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