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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 the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2018-11-07 under 510(k) 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. The listed applicant is Kerr Corporation. The 510(k) number is K182162.

When did OptiBond eXTRa Universal receive FDA 510(k) clearance?

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

Who is the listed applicant for OptiBond eXTRa Universal?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiBond eXTRa Universal?

The FDA product code for OptiBond eXTRa Universal is KLE.

Other records listing Kerr Corporation 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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