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FDA 510(k)

OptiBond eXTRa Universal

K-Number: K182162 · 2018-11-07

ApplicantKerr Corporation
Decision Date2018-11-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OptiBond eXTRa Universal is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2018-11-07 under approval number K182162. 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 OptiBond eXTRa Universal?

OptiBond eXTRa Universal is a medical device that received FDA 510(k) clearance on 2018-11-07. It is manufactured by Kerr Corporation. The 510(k) number is K182162.

When was OptiBond eXTRa Universal approved by the FDA?

OptiBond eXTRa Universal received FDA 510(k) clearance on 2018-11-07, under approval number K182162.

What company makes OptiBond eXTRa Universal?

OptiBond eXTRa Universal is manufactured by Kerr Corporation.

What is the FDA product code for OptiBond eXTRa Universal?

The FDA product code for OptiBond eXTRa Universal is KLE.

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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.

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