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FDA 510(k)

Rainbow 360

K-Number: K222830 · 2023-01-12

ApplicantKerr Corporation
Decision Date2023-01-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rainbow 360 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K222830. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rainbow 360?

Rainbow 360 is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Kerr Corporation. The 510(k) number is K222830.

When did Rainbow 360 receive FDA 510(k) clearance?

Rainbow 360 received FDA 510(k) clearance on 2023-01-12, under 510(k) number K222830.

Who is the listed applicant for Rainbow 360?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rainbow 360?

The FDA product code for Rainbow 360 is KLE.

Other records listing Kerr Corporation as applicant

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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