rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono— 510(k) K232174

Name: FDA 510(k) clearance K232174
Creator: U.S. Food and Drug Administration
Published: 2024-02-23

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K232174 for rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono, Substantially Equivalent on 2024-02-23. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2023-07-21
Decision date: 2024-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.