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FDA 510(k)

Hi-Bond Universal

K-Number: K230465 · 2023-05-22

ApplicantMediclus Co., Ltd.
Decision Date2023-05-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Hi-Bond Universal is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K230465. 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 Hi-Bond Universal?

Hi-Bond Universal is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K230465.

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

Hi-Bond Universal received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230465.

Who is the listed applicant for Hi-Bond Universal?

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

What is the FDA product code for Hi-Bond Universal?

The FDA product code for Hi-Bond Universal is KLE.

Other records listing Mediclus Co., Ltd. as applicant

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.

K254201Any-CemK261728One-Fil LCK260485Any-EtchK260819Any-Com SealK253797One-StopK253167Any-Paste

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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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