FDA 510(k)

BeautiBond Universal

K-Number: K180803 · 2018-09-26

Decision Date2018-09-26

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BeautiBond Universal is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2018-09-26 under approval number K180803. 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 BeautiBond Universal?

BeautiBond Universal is a medical device that received FDA 510(k) clearance on 2018-09-26. It is manufactured by Shofu Dental Corporation. The 510(k) number is K180803.

When was BeautiBond Universal approved by the FDA?

BeautiBond Universal received FDA 510(k) clearance on 2018-09-26, under approval number K180803.

What company makes BeautiBond Universal?

BeautiBond Universal is manufactured by Shofu Dental Corporation.

What is the FDA product code for BeautiBond Universal?

The FDA product code for BeautiBond Universal is KLE.

Other Devices by Shofu Dental Corporation

K161891HC Primer K160596BEAUTIFIL II LS K160086SHOFU Enamel Conditioner K151700BEAUTIFIL II Gingiva K152392VINTAGE LD K172530BEAUTIFIL Flow Plus X

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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.