FDA 510(k)

DenMat Bulk Fill Composite

K-Number: K242097 · 2024-10-15

Decision Date2024-10-15

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DenMat Bulk Fill Composite is a medical device manufactured by Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2024-10-15 under approval number K242097. 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 DenMat Bulk Fill Composite?

DenMat Bulk Fill Composite is a medical device that received FDA 510(k) clearance on 2024-10-15. It is manufactured by Den-Mat Holdings, LLC. The 510(k) number is K242097.

When was DenMat Bulk Fill Composite approved by the FDA?

DenMat Bulk Fill Composite received FDA 510(k) clearance on 2024-10-15, under approval number K242097.

What company makes DenMat Bulk Fill Composite?

DenMat Bulk Fill Composite is manufactured by Den-Mat Holdings, LLC.

What is the FDA product code for DenMat Bulk Fill Composite?

The FDA product code for DenMat Bulk Fill Composite is EBF.

Other Devices by Den-Mat Holdings, LLC

K162967nuance UNIVERSAL

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

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.