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FDA 510(k)

Bright Bond Universal

K-Number: K200153 · 2020-10-28

ApplicantGenoss Co., Ltd.
Decision Date2020-10-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bright Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K200153. 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 Bright Bond Universal?

Bright Bond Universal is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K200153.

When did Bright Bond Universal receive FDA 510(k) clearance?

Bright Bond Universal received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200153.

Who is the listed applicant for Bright Bond Universal?

The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bright Bond Universal?

The FDA product code for Bright Bond Universal is KLE.

Other records listing Genoss Co., Ltd. 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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