Rainbow Shine: FDA 510(k) K151842, Genoss

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK151842	Date14 Jan 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K151842

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K151842
FDA product code: EIH

Device class: Class II
Regulation: 21 CFR Part 872.6660
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent

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

Rainbow Block K092513 9 Oct 2009 FDA record · FDA summary

Cited by

rainbow Shine K160079 10 Nov 2016 FDA record · FDA summary

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

Devices cleared under K151842

2 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 K151842
		UDI-DI	Size and differences
rainbow High Shine AT9822A1 Genoss	AT9822A1 / AT9822A1	08809324760117	Height 22 mm	On the market
rainbow High Shine AT9822A2 Genoss	AT9822A2 / AT9822A2	08809324760124	Height 22 mm	On the market

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Other devices filed under FDA product code EIH (Powder, Porcelain).

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