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FDA 510(k)

Nexus Universal Self-Cure

K-Number: K191548 · 2019-10-11

ApplicantKerr Corporation
Decision Date2019-10-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nexus Universal Self-Cure is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191548. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexus Universal Self-Cure?

Nexus Universal Self-Cure is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Kerr Corporation. The 510(k) number is K191548.

When did Nexus Universal Self-Cure receive FDA 510(k) clearance?

Nexus Universal Self-Cure received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191548.

Who is the listed applicant for Nexus Universal Self-Cure?

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 Nexus Universal Self-Cure?

The FDA product code for Nexus Universal Self-Cure is EMA.

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Related Devices (Code: EMA)

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-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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