FDA 510(k)

nuance UNIVERSAL

K-Number: K162967 · 2017-03-24

Decision Date2017-03-24

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

nuance UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162967. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the nuance UNIVERSAL?

nuance UNIVERSAL is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K162967.

When did nuance UNIVERSAL receive FDA 510(k) clearance?

nuance UNIVERSAL received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162967.

Who is the listed applicant for nuance UNIVERSAL?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for nuance UNIVERSAL?

The FDA product code for nuance UNIVERSAL is EBF.

Other records listing Den-Mat Holdings, LLC as applicant

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.

K242097DenMat Bulk Fill Composite

Related Devices (Code: EBF)

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual CoreVericom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.