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FDA 510(k)

nuance UNIVERSAL

K-Number: K162967 · 2017-03-24

ApplicantDen-Mat Holdings, LLC
Decision Date2017-03-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

nuance UNIVERSAL is a medical device manufactured by Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2017-03-24 under approval 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. It is manufactured by Den-Mat Holdings, LLC. The 510(k) number is K162967.

When was nuance UNIVERSAL approved by the FDA?

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

What company makes nuance UNIVERSAL?

nuance UNIVERSAL is manufactured by Den-Mat Holdings, LLC.

What is the FDA product code for nuance UNIVERSAL?

The FDA product code for nuance UNIVERSAL is EBF.

Other Devices by Den-Mat Holdings, LLC

K242097DenMat Bulk Fill Composite

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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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