FDA 510(k)

Hi-Bond Universal

K-Number: K230465 · 2023-05-22

Decision Date2023-05-22

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Hi-Bond Universal is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under approval 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. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K230465.

When was Hi-Bond Universal approved by the FDA?

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

What company makes Hi-Bond Universal?

Hi-Bond Universal is manufactured by Mediclus Co., Ltd..

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

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

Other Devices by Mediclus Co., Ltd.

K241147Any-Com K232182One-Fil K252465Any-Core K251884One-Fil Putty Injectable K251283Once-Fil Flow K250823Any-Com Flow

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Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

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.