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rainbow Shine

by GENOSS CO., Ltd.

510(k) K160079

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160079 Date10 Nov 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EIH
Device class
Class II
Regulation
21 CFR Part 872.6660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K160079

48 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K160079
UDI-DISize and differences
rainbow shine SH9810A0
Genoss
SH9810A0 / SH9810A008809552960006
Outer Diameter 98 mm
On the market
rainbow shine SH9810A1
Genoss
SH9810A1 / SH9810A108809552960013
Outer Diameter 98 mm
On the market
rainbow shine SH9810A2
Genoss
SH9810A2 / SH9810A208809552960020
Outer Diameter 98 mm
On the market
rainbow shine SH9810WA0
Genoss
SH9810WA0 / SH9810WA008809552960211
Outer Diameter 98 mm
On the market
rainbow shine SH9810WA1
Genoss
SH9810WA1 / SH9810WA108809552960228
Outer Diameter 98 mm
On the market
rainbow shine SH9810WA2
Genoss
SH9810WA2 / SH9810WA208809552960235
Outer Diameter 98 mm
On the market
rainbow shine SH9812A0
Genoss
SH9812A0 / SH9812A008809552960037
Outer Diameter 98 mm
On the market
rainbow shine SH9812A1
Genoss
SH9812A1 / SH9812A108809552960044
Outer Diameter 98 mm
On the market
rainbow shine SH9812A2
Genoss
SH9812A2 / SH9812A208809552960051
Outer Diameter 98 mm
On the market
rainbow shine SH9812WA0
Genoss
SH9812WA0 / SH9812WA008809552960242
Outer Diameter 98 mm
On the market
rainbow shine SH9812WA1
Genoss
SH9812WA1 / SH9812WA108809552960259
Outer Diameter 98 mm
On the market
rainbow shine SH9812WA2
Genoss
SH9812WA2 / SH9812WA208809552960266
Outer Diameter 98 mm
On the market
rainbow shine SH9814A0
Genoss
SH9814A0 / SH9814A008809552960068
Outer Diameter 98 mm
On the market
rainbow shine SH9814A1
Genoss
SH9814A1 / SH9814A108809552960075
Outer Diameter 98 mm
On the market
rainbow shine SH9814A2
Genoss
SH9814A2 / SH9814A208809552960082
Outer Diameter 98 mm
On the market
rainbow shine SH9814WA0
Genoss
SH9814WA0 / SH9814WA008809552960273
Outer Diameter 98 mm
On the market
rainbow shine SH9814WA1
Genoss
SH9814WA1 / SH9814WA108809552960280
Outer Diameter 98 mm
On the market
rainbow shine SH9814WA2
Genoss
SH9814WA2 / SH9814WA208809552960297
Outer Diameter 98 mm
On the market
rainbow shine SH9816A0
Genoss
SH9816A0 / SH9816A008809552960099
Outer Diameter 98 mm
On the market
rainbow shine SH9816A1
Genoss
SH9816A1 / SH9816A108809552960105
Outer Diameter 98 mm
On the market
rainbow shine SH9816A2
Genoss
SH9816A2 / SH9816A208809552960112
Outer Diameter 98 mm
On the market
rainbow shine SH9816WA0
Genoss
SH9816WA0 / SH9816WA008809552960303
Outer Diameter 98 mm
On the market
rainbow shine SH9816WA1
Genoss
SH9816WA1 / SH9816WA108809552960310
Outer Diameter 98 mm
On the market
rainbow shine SH9816WA2
Genoss
SH9816WA2 / SH9816WA208809552960327
Outer Diameter 98 mm
On the market
rainbow shine SH9818A0
Genoss
SH9818A0 / SH9818A008809552960129
Outer Diameter 98 mm
On the market
rainbow shine SH9818A1
Genoss
SH9818A1 / SH9818A108809552960136
Outer Diameter 98 mm
On the market
rainbow shine SH9818A2
Genoss
SH9818A2 / SH9818A208809552960143
Outer Diameter 98 mm
On the market
rainbow shine SH9818WA0
Genoss
SH9818WA0 / SH9818WA008809552960334
Outer Diameter 98 mm
On the market
rainbow shine SH9818WA1
Genoss
SH9818WA1 / SH9818WA108809552960341
Outer Diameter 98 mm
On the market
rainbow shine SH9818WA2
Genoss
SH9818WA2 / SH9818WA208809552960358
Outer Diameter 98 mm
On the market
rainbow shine SH9820A0
Genoss
SH9820A0 / SH9820A008809552960150
Outer Diameter 98 mm
On the market
rainbow shine SH9820A1
Genoss
SH9820A1 / SH9820A108809552960167
Outer Diameter 98 mm
On the market
rainbow shine SH9820A2
Genoss
SH9820A2 / SH9820A208809552960174
Outer Diameter 98 mm
On the market
rainbow shine SH9820WA0
Genoss
SH9820WA0 / SH9820WA008809552960365
Outer Diameter 98 mm
On the market
rainbow shine SH9820WA1
Genoss
SH9820WA1 / SH9820WA108809552960372
Outer Diameter 98 mm
On the market
rainbow shine SH9820WA2
Genoss
SH9820WA2 / SH9820WA208809552960389
Outer Diameter 98 mm
On the market
rainbow shine SH9822A0
Genoss
SH9822A0 / SH9822A008809552960181
Outer Diameter 98 mm
On the market
rainbow shine SH9822A1
Genoss
SH9822A1 / SH9822A108809552960198
Outer Diameter 98 mm
On the market
rainbow shine SH9822A2
Genoss
SH9822A2 / SH9822A208809552960204
Outer Diameter 98 mm
On the market
rainbow shine SH9822WA0
Genoss
SH9822WA0 / SH9822WA008809552960396
Outer Diameter 98 mm
On the market
rainbow shine SH9822WA1
Genoss
SH9822WA1 / SH9822WA108809552960402
Outer Diameter 98 mm
On the market
rainbow shine SH9822WA2
Genoss
SH9822WA2 / SH9822WA208809552960419
Outer Diameter 98 mm
On the market
rainbow shine SH9824A0
Genoss
SH9824A0 / SH9824A008809552962932
Outer Diameter 98 mm
On the market
rainbow shine SH9824A1
Genoss
SH9824A1 / SH9824A108809552962949
Outer Diameter 98 mm
On the market
rainbow shine SH9824A2
Genoss
SH9824A2 / SH9824A208809552962956
Outer Diameter 98 mm
On the market
rainbow shine SH9824WA0
Genoss
SH9824WA0 / SH9824WA008809552962963
Outer Diameter 98 mm
On the market
rainbow shine SH9824WA1
Genoss
SH9824WA1 / SH9824WA108809552962970
Outer Diameter 98 mm
On the market
rainbow shine SH9824WA2
Genoss
SH9824WA2 / SH9824WA208809552962987
Outer Diameter 98 mm
On the market

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