rainbow Shine— 510(k) K160079

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K160079 for rainbow Shine, Substantially Equivalent on 2016-11-10. 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: 2016-01-14
Decision date: 2016-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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K262195 — Dandy Ceramic Stain and Glaze2026-06-30
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More clearances from Genoss Co., Ltd.

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K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono2024-02-23
K231480 — Bright MTA Sealer Plus2023-07-28

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