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rainbow Shine

FDA 510(k)

Class II (US FDA 510(k))

510(k) K160079

by GENOSS CO., Ltd.

Identifiers

510(k) Number
K160079 FDA 510(k)
FDA Product Code
EIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6660 FDA 510(k)
Regulation Number
872.6660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

rainbow Shine is a dental material intended for use in restorative dentistry. It is a zirconia-based material used for the fabrication of dental crowns, bridges, and other prosthetic devices. The device is supplied as a pre-shaded or multi-layered block or disc for milling and sintering in the dental laboratory.

The device is manufactured by Genoss Co., Ltd. and is supplied in various sizes and configurations, including the catalog number SH9810WA1. It is intended for single-patient use and must be handled in accordance with standard infection control practices. The device is not evaluated for MRI safety and should be stored in a dry, cool environment. It received FDA 510(k) clearance under number K160079.

Frequently asked questions

What is rainbow Shine used for in dentistry?

rainbow Shine is a zirconia-based dental material used to fabricate crowns, bridges, and other prosthetic devices in restorative dentistry. It is milled and sintered in the lab before clinical use.

How is rainbow Shine supplied and what model is available?

It is supplied as a pre-shaded or multi-layered block or disc. The specific catalog number is SH9810WA1, available in various sizes and configurations for different clinical needs.

Is rainbow Shine sterile and intended for single or multiple patients?

rainbow Shine is intended for single-patient use. It is not supplied sterile, and standard infection control practices must be followed during handling and processing.

What are the storage requirements for rainbow Shine?

The material should be stored in a dry, cool environment. It is not evaluated for MRI safety, so appropriate precautions should be taken in imaging settings.

What regulatory clearance does rainbow Shine have?

rainbow Shine received FDA 510(k) clearance under number K160079. It was determined substantially equivalent to existing devices in the dental material category.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RevMed Marketplace | Connecting the Dots, rainbow Shine — FDA 510 (k) K160079 | MedTracker, rainbow Shine (K160079) — FDA 510 (k) | Innolitics, Zirconia dental material - Rainbow™ Shine-T - Genoss - for dental ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GENOSS CO., Ltd.

Sources (1)

  • FDA 510(k) K160079 24 fields · synced Sep 21, 2026